A Research Study Looking at How Well a Combination of the... | NCT05144984 | Trialant
NCT05144984
Sponsor
Novo Nordisk A/S
Status
Completed
Last Update Posted
Apr 9, 2026Actual
Enrollment
500Actual
Phase
Phase 2
Conditions
Diabetes Mellitus, Type 2
Interventions
NNC0480-0389
Semaglutide
Placebo (NNC080-0389)
Placebo (semaglutide)
Countries
United States
Bulgaria
Denmark
Greece
Hungary
Japan
Poland
Russia
Serbia
Protocol Section
Identification Module
NCT ID
NCT05144984
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NN9389-4606
Secondary IDs
ID
Type
Description
Link
U1111-1259-2741
Other Identifier
World Health Organization (WHO)
2020-004863-14
EudraCT Number
jRCT2031210474
Other Identifier
Japanese Registration Number
Brief Title
A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
Official Title
Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study
Acronym
Not provided
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 29, 2021Actual
Primary Completion Date
Feb 13, 2023Actual
Completion Date
Mar 23, 2023Actual
First Submitted Date
Nov 22, 2021
First Submission Date that Met QC Criteria
Nov 22, 2021
First Posted Date
Dec 6, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Feb 13, 2026
Results First Submitted that Met QC Criteria
Mar 21, 2026
Results First Posted Date
Apr 9, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 12, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Apr 9, 2026Actual
Last Update Submitted Date
Mar 21, 2026
Last Update Posted Date
Apr 9, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novo Nordisk A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.
The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.
Participants will either get:
Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).
NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.
Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.
Participant must inject the study medicines themself into the stomach, thigh, or upper arm.
The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.
Women can only take part in the study if they are not able to become pregnant
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
500Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
2.4 mg semaglutide + 2.4 mg NNC0480-0389
Experimental
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Drug: Placebo (NNC080-0389)
Drug: Placebo (semaglutide)
2.4 mg semaglutide + 7.2 mg NNC0480-0389
Experimental
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Drug: NNC0480-0389
Drug: Semaglutide
2.4 mg semaglutide + 12.0 mg NNC0480-0389
Experimental
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Drug: NNC0480-0389
Drug: Semaglutide
2.4 mg semaglutide + 21.6 mg NNC0480-0389
Experimental
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NNC0480-0389
Drug
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
2.4 mg semaglutide + 12.0 mg NNC0480-0389
2.4 mg semaglutide + 2.4 mg NNC0480-0389
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose
HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
BMI greater than or equal to 25 and below 40 kg/m^2
Exclusion Criteria:
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Transparency (dept. 1452)
Novo Nordisk A/S
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pinnacle Research Group LLC
Anniston
Alabama
36207
United States
Synexus Clinical Research
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
The trial had a 34-week intervention period (10 weeks of dose escalation period and followed by two 12 -week maintenance period), followed by a 5-week follow-up period.
Recruitment Details
The trial was conducted in 9 countries (86 sites screened/83 randomised participants) as follows: Bulgaria: 6/6; Denmark: 3/3; Greece: 7/7; Hungary: 9/9; Japan: 6/6; Poland: 10/10; Russia: 4/4; Serbia: 3/3; United States of America (USA): 38/35. In addition, Hungary (1 site), Poland (1 site), Serbia (1 site) and USA (5 site) were approved by the institutional review board, but did not screen any participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
Change From Baseline in Body Weight (Kilogram [kg])
Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Percent Change From Baseline in Body Weight
Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Change From Baseline in Waist Circumference
Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Change From Baseline in Systolic Blood Pressure (SBP)
Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in Total Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in Triglycerides - Ratio to Baseline
Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline
Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline
Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Baseline (week 0), (week 34)
Number of Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.
Baseline (week 0) to (week 39)
Glendale
Arizona
85308
United States
University of Arizona/Banner Health
Phoenix
Arizona
85006
United States
American Clinical Trials
Buena Park
California
90620
United States
San Fernando Valley Hlth Inst, LLC
Canoga Park
California
91304
United States
Velocity Clin Res-Chula Vista
Chula Vista
California
91911
United States
Headlands Research California, LLC
Escondido
California
92025
United States
Valley Research
Fresno
California
93720
United States
Providence Medical Foundation
Fullerton
California
92835
United States
Velocity Clinical Research San Diego
La Mesa
California
91942
United States
First Valley Med Grp Lancaster
Lancaster
California
93534
United States
Torrance Clin Res Inst, Inc.
Lomita
California
90717
United States
Velocity Clin Res Los Angeles
Los Angeles
California
90017
United States
Valley Clinical Trials, Inc.
Northridge
California
91325
United States
Artemis Insitute for Clin Res
Riverside
California
92503
United States
Artemis Institute for Clin Res
San Diego
California
92103
United States
Shahram Jacobs MD Inc.
Sherman Oaks
California
91403
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Northeast Research Institute
Jacksonville
Florida
32204
United States
Reyes Clinical Research, Inc
Miami
Florida
33175
United States
South Broward Research LLC
Miramar
Florida
33027
United States
Clinical Trial Res Assoc,Inc
Plantation
Florida
33324
United States
Progressive Medical Research
Port Orange
Florida
32127
United States
Headlands Research - Sarasota
Sarasota
Florida
34243
United States
Appalachian Clinical Res LLC
Adairsville
Georgia
30103
United States
Solaris Clinical Research
Meridian
Idaho
83646
United States
Cedar-Crosse Research Center
Chicago
Illinois
60607
United States
Macoupin Research Group
Gillespie
Illinois
62033
United States
UnityPoint Health-Diabetes Care Center
Peoria
Illinois
61603
United States
Clin Invest Spec, Inc
Wauconda
Illinois
60084
United States
Iowa Diabetes & Endo Res Ctr
West Des Moines
Iowa
50265
United States
Cotton O'Neil Diab & Endo Ctr
Topeka
Kansas
66606
United States
The Research Group of Lexington LLC
Lexington
Kentucky
40503
United States
L-MARC Research Center
Louisville
Kentucky
40213
United States
Centex Studies, Inc._Lake Charles
Lake Charles
Louisiana
70601
United States
Endo And Metab Cons
Rockville
Maryland
20852
United States
Brigham & Women's Hospital
Boston
Massachusetts
02115-5804
United States
Arcturus HC PLC Troy Med Res
Troy
Michigan
48098
United States
StudyMetrix Research LLC
City of Saint Peters
Missouri
63303
United States
Mercury Str Med Grp, PLLC
Butte
Montana
59701
United States
Princeton Endo Assoc
Princeton
New Jersey
08540
United States
Premier Research Inc.
Trenton
New Jersey
08611
United States
AMC Community Endocrinology
Albany
New York
12203
United States
Mid Hudson Med Res-New Windsor
New Windsor
New York
12553
United States
University of North Carolina
Chapel Hill
North Carolina
27514
United States
PharmQuest Life Sciences LLC
Greensboro
North Carolina
27408
United States
Physicians East Endocrinology
Greenville
North Carolina
27834
United States
Piedmont Healthcare/Research
Statesville
North Carolina
28625
United States
Lillestol Research LLC
Fargo
North Dakota
58104
United States
Albert J Weisbrot
Mason
Ohio
45040-6815
United States
Advanced Med Res Maumee
Maumee
Ohio
43537
United States
Intend Research
Norman
Oklahoma
73069
United States
Essential Medical Research LLC
Tulsa
Oklahoma
74137
United States
CCT Research
Hatboro
Pennsylvania
19040
United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh
Pennsylvania
15236
United States
Spartanburg Medical Research
Spartanburg
South Carolina
29303
United States
Chattanooga Medical Research, LLC
Chattanooga
Tennessee
37404
United States
Clinical Neuroscience Solutions
Memphis
Tennessee
38119
United States
Velocity Clinical Res-Dallas
Dallas
Texas
75230
United States
UT Southwestern Med Cntr
Dallas
Texas
75390-9302
United States
Centex Studies, Inc.
Houston
Texas
77058
United States
Juno Research, LLC
Houston
Texas
77074
United States
Southwest Clinical Trials
Houston
Texas
77074
United States
Centex Studies
Houston
Texas
77090
United States
Quality Research Inc
San Antonio
Texas
78209
United States
VIP Trials_San Antonio
San Antonio
Texas
78230
United States
Consano Clinical Research, LLC
Shavano Park
Texas
78231
United States
Simcare Medical Research, LLC
Sugar Land
Texas
77478
United States
Advanced Research Institute
Ogden
Utah
84405
United States
York Clinical Research LLC
Norfolk
Virginia
23504
United States
Capital Clin Res Ctr,LLC
Olympia
Washington
98502
United States
Medical centre Zdrave 1 OOD
Kozloduy
3320
Bulgaria
IPMC - Dr. Elizabeta Dimitrova
Petrich
2850
Bulgaria
UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
Sofia
1431
Bulgaria
Medical centre - Doverie AD
Sofia
1632
Bulgaria
UMHAT Sofiamed EAD
Sofia
1797
Bulgaria
Prevencia - 2000 - MCOC OOD
Stara Zagora
6000
Bulgaria
MC Berbatov EOOD, Cherni Drin
Yambol
8600
Bulgaria
Aarhus Universitetshospital Diabetes og Hormonsygdomme
Aarhus N
8200
Denmark
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki
54645
Greece
"Thermi" Private Hosital
Thessaloniki
57001
Greece
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
Pécs
Baranya Vármegye
7623
Hungary
Debreceni Egyetem Belgyógyászati Klinika
Debrecen
Hajdú-Bihar
4032
Hungary
Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház
Békéscsaba
5600
Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest
1036
Hungary
SOTE ÁOK I. sz. Belgyógyászati és Onkológiai Klinika
Budapest
1083
Hungary
Bajcsy-Zsilinszky Kórház
Budapest
1106
Hungary
MED-TIMA Kft.
Budapest
1132
Hungary
MH Egészségügyi Központ
Budapest
1134
Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
Debrecen
4043
Hungary
Békés Megyei Központi Kórház
Gyula
5700
Hungary
Kaposi Mór Oktató Kórház
Kaposvár
7400
Hungary
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
Szombathely
9700
Hungary
Szent Borbála Kórház
Tatabánya
2800
Hungary
Naka Kinen Clinic_Internal medicine
Ibaraki
311-0113
Japan
Yoshimura clinic
Kumamoto
861-8039
Japan
Kansai Electric Power Hospital_Center for Diabetes
Osaka
553-0003
Japan
Tokyo Center Clinic
Tokyo
103-0028
Japan
ToCROM Clinic_Internal Medicine
Tokyo
160-0008
Japan
Higashi-shinjuku clinic
Tokyo
169-0072
Japan
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok
Podlaskie Voivodeship
15-879
Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow
31-501
Poland
Globe Badania Kliniczne Sp. z o.o.
Kłodzko
57-300
Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz
90-338
Poland
FutureMeds Sp. z o.o. Lodz
Lodz
91-363
Poland
Diabetica Sp. z o.o.
Nysa
48-300
Poland
Centrum Medyczne dr Sudnik
Sokółka
16-100
Poland
Osrodek Badan Klinicznych Clinsante
Torun
87-100
Poland
Centrum Medyczne AMED Warszawa
Warsaw
00-215
Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw
02-507
Poland
FutureMeds Sp. z o.o.
Wroclaw
50-088
Poland
SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze
Zabrze
41-800
Poland
Velocity Nova Sp. z o.o.
Staszów
Świętokrzyskie Voivodeship
28-200
Poland
Tumen State Medical University
Tyumen
Russia
625023
Russia
LLC RC Medical
Novosibirsk
630005
Russia
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza
440026
Russia
Medinet LLC
Saint Petersburg
194356
Russia
CHC Zvezdara, Clinical department for endocrinology
Belgrade
11000
Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade
11000
Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac
34000
Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr
Kragujevac
34000
Serbia
FG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
FG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
FG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
FG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
FG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
FG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
FG00077 subjects
FG00174 subjects
FG00277 subjects
FG00377 subjects
FG00475 subjects
FG00559 subjects
FG00661 subjects
Full Analysis Set (FAS)
FG00077 subjects
FG00174 subjects
FG00277 subjects
FG00377 subjects
FG00475 subjects
FG00559 subjects
FG00661 subjects
Safety Analysis Set (SAS)
FG00077 subjects
FG00174 subjects
FG00277 subjects
FG00377 subjects
FG00475 subjects
FG00559 subjects
FG00661 subjects
Exposed
FG00077 subjects
FG00174 subjects
FG00277 subjects
FG00377 subjects
FG00475 subjects
FG00559 subjects
FG00661 subjects
COMPLETED
FG00074 subjects
FG00172 subjects
FG00274 subjects
FG00374 subjects
FG00472 subjects
FG00557 subjects
FG00659 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0052 subjects
FG0062 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Investigator decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full analysis set (FAS) included all randomised participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
BG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
BG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
BG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
BG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
BG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
BG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00077
BG00174
BG00277
BG00377
BG00475
BG00559
BG00661
BG007500
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00059± 11
BG00157± 10
BG00258± 10
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00026
BG00133
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG0017
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Mean
Standard Deviation
millimoles per litre (mmol/L)
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00158
OG00263
OG003
Title
Denominators
Categories
Title
Measurements
OG000-3.9± 2.6
OG001-3.4± 2.1
OG002-3.8± 2.4
OG003
Secondary
Change From Baseline in Body Weight (Kilogram [kg])
Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Mean
Standard Deviation
Kilogram (kg)
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
Secondary
Percent Change From Baseline in Body Weight
Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Mean
Standard Deviation
Percent Change of body weight
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
Secondary
Change From Baseline in Waist Circumference
Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Mean
Standard Deviation
Centimeter (cm)
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
Secondary
Change From Baseline in Systolic Blood Pressure (SBP)
Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
Secondary
Relative Change From Baseline in Total Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of total cholesterol
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of HDL cholesterol
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of LDL cholesterol
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of VLDL cholesterol
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Relative Change From Baseline in Triglycerides - Ratio to Baseline
Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of triglycerides
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline
Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of free fatty acids
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline
Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of ApoB
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio of hsCRP
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Secondary
Number of Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.
Safety Analysis Set (SAS) included all participants exposed to randomised treatment.
Posted
Number
Events
Baseline (week 0) to (week 39)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
Primary
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Mean
Standard Deviation
Percentage point of HbA1c
Baseline (week 0), (week 34)
ID
Title
Description
OG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
OG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
Time Frame
From baseline (week 0) to week 39
Description
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
0
77
6
77
40
77
EG001
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
0
74
3
74
44
74
EG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
0
77
2
77
36
77
EG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
0
77
5
77
37
77
EG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
0
75
3
75
34
75
EG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
0
59
2
59
25
59
EG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
0
61
2
61
23
61
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected77 at risk
EG0040 events0 affected75 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected61 at risk
Acute hepatic failure
Hepatobiliary disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Congestive cardiomyopathy
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0021 events1 affected77 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Giant cell arteritis
Vascular disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Pancreatic disorder
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Parathyroid cyst
Endocrine disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Portal hypertension
Hepatobiliary disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25
Systematic Assessment
EG0002 events2 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0021 events1 affected77 at risk
EG003
VIth nerve paralysis
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected74 at risk
EG0021 events1 affected77 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Amylase increased
Investigations
MedDRA 25
Systematic Assessment
EG0003 events3 affected77 at risk
EG0014 events3 affected74 at risk
EG0020 events0 affected77 at risk
EG0035 events5 affected77 at risk
EG0041 events1 affected75 at risk
EG0051 events1 affected59 at risk
EG0060 events0 affected61 at risk
Asthenia
General disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0011 events1 affected74 at risk
EG0023 events2 affected77 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25
Systematic Assessment
EG0002 events2 affected77 at risk
EG0015 events5 affected74 at risk
EG0023 events3 affected77 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25
Systematic Assessment
EG0007 events6 affected77 at risk
EG0014 events4 affected74 at risk
EG0026 events6 affected77 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0004 events4 affected77 at risk
EG0017 events6 affected74 at risk
EG0027 events7 affected77 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25
Systematic Assessment
EG0004 events4 affected77 at risk
EG0018 events8 affected74 at risk
EG0024 events3 affected77 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG00025 events11 affected77 at risk
EG00130 events16 affected74 at risk
EG00222 events11 affected77 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0004 events4 affected77 at risk
EG0013 events3 affected74 at risk
EG0024 events4 affected77 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0004 events4 affected77 at risk
EG0014 events3 affected74 at risk
EG0022 events2 affected77 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0002 events1 affected77 at risk
EG0015 events2 affected74 at risk
EG0022 events1 affected77 at risk
EG003
Fatigue
General disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0011 events1 affected74 at risk
EG0023 events3 affected77 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0002 events1 affected77 at risk
EG0012 events2 affected74 at risk
EG0022 events2 affected77 at risk
EG003
Headache
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0009 events6 affected77 at risk
EG0013 events3 affected74 at risk
EG0027 events5 affected77 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected74 at risk
EG0022 events2 affected77 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25
Systematic Assessment
EG0002 events2 affected77 at risk
EG0015 events4 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Injection site erythema
General disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected74 at risk
EG00210 events4 affected77 at risk
EG003
Injection site pruritus
General disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0012 events1 affected74 at risk
EG0020 events0 affected77 at risk
EG003
Injection site reaction
General disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected77 at risk
EG0013 events2 affected74 at risk
EG0024 events2 affected77 at risk
EG003
Lipase increased
Investigations
MedDRA 25
Systematic Assessment
EG0004 events4 affected77 at risk
EG00110 events9 affected74 at risk
EG0022 events2 affected77 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25
Systematic Assessment
EG0004 events3 affected77 at risk
EG0014 events4 affected74 at risk
EG0024 events4 affected77 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG00021 events15 affected77 at risk
EG00125 events9 affected74 at risk
EG0028 events5 affected77 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25
Systematic Assessment
EG0000 events0 affected77 at risk
EG0012 events2 affected74 at risk
EG0022 events2 affected77 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0004 events4 affected77 at risk
EG0019 events7 affected74 at risk
EG0024 events4 affected77 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00160
OG00265
OG00365
OG00460
OG00543
OG00637
Title
Denominators
Categories
Title
Measurements
OG000-8.9± 5.8
OG001-12± 7.7
OG002-10± 5.9
OG003-12± 5.4
OG004-9.8± 5.8
OG005-4.7± 5.1
OG006-2.6± 3.9
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00160
OG00265
OG00365
OG00460
OG00543
OG00637
Title
Denominators
Categories
Title
Measurements
OG000-9.3± 5.8
OG001-13± 7.3
OG002-11± 5.8
OG003-13± 5.4
OG004-10± 6.3
OG005-4.3± 4.5
OG006-2.7± 4.1
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00160
OG00265
OG00365
OG00460
OG00543
OG00637
Title
Denominators
Categories
Title
Measurements
OG000-8± 5
OG001-11± 7
OG002-9± 7
OG003-10± 7
OG004-8± 6
OG005-5± 5
OG006-3± 5
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00160
OG00265
OG00365
OG00460
OG00543
OG00637
Title
Denominators
Categories
Title
Measurements
OG000-6± 12
OG001-10± 14
OG002-9± 13
OG003-13± 12
OG004-5± 16
OG005-3± 12
OG0060± 8
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00156
OG00264
OG00364
OG00459
OG00542
OG00636
Title
Denominators
Categories
Title
Measurements
OG0000.94± 19.7
OG0010.89± 22.7
OG0020.90± 21.7
OG0030.90± 17.3
OG0040.93± 18.2
OG0051.00± 22.9
OG0060.96± 16.2
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00157
OG00262
OG00364
OG00459
OG00542
OG00635
Title
Denominators
Categories
Title
Measurements
OG0001.05± 17.6
OG0011.06± 19.8
OG0021.07± 16.7
OG0031.00± 16.0
OG0041.04± 15.6
OG0051.04± 16.2
OG0061.04± 17.0
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00060
OG00156
OG00261
OG00363
OG00458
OG00541
OG00634
Title
Denominators
Categories
Title
Measurements
OG0000.95± 28.4
OG0010.85± 46.5
OG0020.91± 37.5
OG0030.88± 36.0
OG0040.95± 32.2
OG0050.96± 53.5
OG0060.96± 29.8
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00156
OG00262
OG00364
OG00459
OG00542
OG00635
Title
Denominators
Categories
Title
Measurements
OG0000.75± 54.0
OG0010.76± 46.4
OG0020.72± 48.9
OG0030.78± 48.2
OG0040.72± 39.9
OG0050.95± 47.9
OG0060.86± 44.5
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00156
OG00262
OG00364
OG00459
OG00542
OG00635
Title
Denominators
Categories
Title
Measurements
OG0000.75± 53.9
OG0010.76± 46.1
OG0020.72± 49.1
OG0030.78± 47.8
OG0040.72± 40.0
OG0050.96± 47.8
OG0060.86± 44.7
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00157
OG00264
OG00365
OG00458
OG00543
OG00635
Title
Denominators
Categories
Title
Measurements
OG0000.85± 76.1
OG0010.74± 66.0
OG0020.77± 43.5
OG0030.75± 64.9
OG0040.88± 42.3
OG0050.96± 51.1
OG0060.91± 47.3
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00060
OG00158
OG00265
OG00365
OG00459
OG00543
OG00636
Title
Denominators
Categories
Title
Measurements
OG0000.90± 22.8
OG0010.84± 25.7
OG0020.85± 23.5
OG0030.85± 22.1
OG0040.91± 18.4
OG0051.00± 28.2
OG0060.94± 14.7
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00061
OG00157
OG00264
OG00365
OG00459
OG00543
OG00635
Title
Denominators
Categories
Title
Measurements
OG0000.56± 107.0
OG0010.54± 136.9
OG0020.64± 147.9
OG0030.66± 135.5
OG0040.61± 141.5
OG0050.82± 89.7
OG0060.93± 201.6
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00077
OG00174
OG00277
OG00377
OG00475
OG00559
OG00661
Title
Denominators
Categories
Title
Measurements
OG000229
OG001304
OG002206
OG003308
OG004271
OG005240
OG00695
OG002
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
OG003
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
OG004
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
OG005
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
OG006
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
Units
Counts
Participants
OG00077
OG00174
OG00277
OG00377
OG00475
OG00559
OG00661
Title
Denominators
Categories
Title
Measurements
OG000-2.3± 0.9
OG001-2.2± 0.8
OG002-2.2± 1.1
OG003-2.3± 1.0
OG004-2.3± 0.9
OG005-1.1± 1.1
OG006-0.4± 1.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Hypothetical estimand
ANCOVA
<0.0001
Estimated treatment difference
-1.9
2-Sided
95
-2.3
-1.4
Superiority
Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.
OG001
OG006
Hypothetical estimand
ANCOVA
<0.0001
Estimated treatment difference
-2.0
2-Sided
95
-2.5
-1.5
Superiority
Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.
OG002
OG006
Hypothetical estimand
ANCOVA
<0.0001
Estimated treatment difference
-1.9
2-Sided
95
-2.4
-1.5
Superiority
Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.
OG003
OG006
Hypothetical estimand
ANCOVA
<0.0001
Estimated treatment difference
-1.9
2-Sided
95
-2.4
-1.5
Superiority
Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.