A Research Study to Investigate How Well NNC0165-1875 in... | NCT04969939 | Trialant
NCT04969939
Sponsor
Novo Nordisk A/S
Status
Completed
Last Update Posted
Jan 8, 2026Actual
Enrollment
120Actual
Phase
Phase 2
Conditions
Obesity
Interventions
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Semaglutide 2.4 mg and placebo 2.0 mg
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Semaglutide 2.4 mg and placebo 1.0 mg
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04969939
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NN9775-4708
Secondary IDs
ID
Type
Description
Link
U1111-1254-9046
Other Identifier
WHO
Brief Title
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
Official Title
Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity
Acronym
Not provided
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Jan 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
Jul 15, 2021Actual
Primary Completion Date
Dec 6, 2022Actual
Completion Date
Jan 30, 2023Actual
First Submitted Date
Jul 9, 2021
First Submission Date that Met QC Criteria
Jul 9, 2021
First Posted Date
Jul 21, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Dec 3, 2025
Results First Submitted that Met QC Criteria
Jan 7, 2026
Results First Posted Date
Jan 8, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 5, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jan 8, 2026Actual
Last Update Submitted Date
Jan 7, 2026
Last Update Posted Date
Jan 8, 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
The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.
Detailed Description
Not provided
Conditions Module
Conditions
Obesity
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
120Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Experimental
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)
Placebo Comparator
Participants will receive placebo as an add on to semaglutide 2.4 mg.
Drug: Semaglutide 2.4 mg and placebo 2.0 mg
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Experimental
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)
Placebo Comparator
Participants will receive placebo as an add on to semaglutide 2.4 mg.
Drug: Semaglutide 2.4 mg and placebo 1.0 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Drug
NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Part 1: From time of dosing (day 1) to follow-up (week 24)
Part 2b: Percentage Change in Body Weight
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2: Randomisation (week 32), end of treatment (week 48)
Secondary Outcomes
Measure
Description
Time Frame
Part 2b: Change in Body Weight (kg)
Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
Male or female, age above or equal to 18 years at the time of signing informed consent.
BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.
Exclusion Criteria:
HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.
History of type 1 or type 2 diabetes mellitus.
Treatment with glucose-lowering agent(s) within 90 days before screening.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
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
Univ of Alabama Birmingham
Birmingham
Alabama
35294
United States
Anaheim Clinical Trials, LLC
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 consisted of part 1 and 2. Part 1: 24 weeks (16-week treatment + 8 week follow up). In part 1 participants received NNC0165-1875 1.0 milligrams (mg) / matching placebo or NNC0165-1875 2.0 mg / matching placebo with semaglutide 2.4 mg. Part 2 further consisted of open-label run-in part (part 2a) of 32 weeks where participants received semaglutide and part 2b of 16 weeks where participants received NNC0165-1875 or NNC0165-1875 placebo with semaglutide s.c. 2.4 mg and 8-week follow up.
Recruitment Details
The trial was conducted at 14 sites in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly subcutaneous (s.c) injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
Periods
Title
Milestones
Reasons Not Completed
Part 1 (24 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 5, 2022
Dec 3, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Drug
NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Semaglutide 2.4 mg and placebo 1.0 mg
Drug
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Plasma Glucose (FPG)
Change in FPG (measured in millimoles per liter [mmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Insulin
Change in fasting insulin (measured in picomoles per liter [pmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Waist Circumference
Change in waist circumference (measured in centimeter [cm]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)
Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)
Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)
Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
From randomisation (week 32) to end of the trial (week 56)
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
From randomisation (week 32) to end of the trial (week 56)
Anaheim
California
92801
United States
Profil Institute For Clinical Research Inc
Chula Vista
California
91911
United States
Velocity Clin Res Los Angeles
Los Angeles
California
90017
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Jacksonville Ctr For Clin Res
Jacksonville
Florida
32216
United States
Endo Res Solutions Inc
Roswell
Georgia
30076
United States
East West Med Res Inst
Honolulu
Hawaii
96814
United States
Evanston Premier Hlthcr Res
Skokie
Illinois
60077
United States
Altasciences Clinical Kansas, Inc.
Overland Park
Kansas
66212
United States
L-MARC Research Center
Louisville
Kentucky
40213
United States
AMC Community Endocrinology
Albany
New York
12206
United States
NYC Research, Inc.
New York
New York
10016
United States
PharmQuest Life Sciences LLC
Greensboro
North Carolina
27408
United States
Accellacare
Wilmington
North Carolina
28401
United States
Medical Uni of SC Charleston
Charleston
South Carolina
29425
United States
Coastal Carolina Res Ctr.
North Charleston
South Carolina
29405
United States
Texas Diabetes & Endocrinology, P.A._Austin
Austin
Texas
78749
United States
Soltero Cardiovascular Research Center
Dallas
Texas
75226
United States
Texas Diabetes & Endocrinology, P.A._Austin
Round Rock
Texas
78681
United States
Chrysalis Clinical Research
St. George
Utah
84790
United States
Washington Cntr Weight Mgmt
Arlington
Virginia
22206
United States
Health Res of Hampton Roads
Newport News
Virginia
23606
United States
National Clin Res Inc.
Richmond
Virginia
23294
United States
Selma Medical Associates
Winchester
Virginia
22601-3834
United States
FG001
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
FG002
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
FG003
Part 2a (Run-in Period): Semaglutide 2.4 mg
Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg.
FG004
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
FG005
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
FG006
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
FG0008 subjects
FG0018 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0008 subjects
FG0018 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Part 2a: Run in Period (32 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00396 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00383 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00313 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 2b (16 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00447 subjectsParticipants who achieved target dose of semaglutide 2.4 mg in Run in part randomized to Part 2b.
FG0058 subjectsParticipants who achieved target dose of semaglutide 2.4 mg in Run in part randomized to Part 2b.
FG00628 subjectsParticipants who achieved target dose of semaglutide 2.4 mg in Run in part randomized to Part 2b.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis set (SAS) included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
BG001
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
BG002
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
BG003
Part 2
All Participants randomised in Part 2.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0018
BG0028
BG00396
BG004120
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
BG00044± 12
BG00145± 14
BG00243± 13
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
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
Primary
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product This outcome measure is applicable for reported arms only.
Posted
Number
Events
Part 1: From time of dosing (day 1) to follow-up (week 24)
ID
Title
Description
OG000
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
OG001
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
OG002
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Title
Measurements
OG00056
OG00171
OG00237
Primary
Part 2b: Percentage Change in Body Weight
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Full analysis set (FAS) included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Percentage change in body weight
Part 2: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Change in Body Weight (kg)
Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
kilograms (kg)
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Percentage point of HbA1c
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Change in Fasting Plasma Glucose (FPG)
Change in FPG (measured in millimoles per liter [mmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all partcipants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
mmol/l
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Change in Fasting Insulin
Change in fasting insulin (measured in picomoles per liter [pmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
pmol/l
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Change in Waist Circumference
Change in waist circumference (measured in centimeter [cm]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
cm
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)
Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Ratio of total cholesterol
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Ratio of HDL cholesterol
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Ratio of LDL cholesterol
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Ratio of VLDL cholesterol
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)
Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Ratio of triglycerides
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)
Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Posted
Mean
Standard Deviation
Ratio of free fatty acids
Part 2b: Randomisation (week 32), end of treatment (week 48)
ID
Title
Description
OG000
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
Secondary
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.
Posted
Number
Events
From randomisation (week 32) to end of the trial (week 56)
ID
Title
Description
OG000
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Secondary
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.
Posted
Number
Events
From randomisation (week 32) to end of the trial (week 56)
ID
Title
Description
OG000
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
OG001
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Time Frame
From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
Description
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
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
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
0
8
0
8
8
8
EG001
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
0
8
1
8
8
8
EG002
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
0
8
0
8
8
8
EG003
Part 2a (Run-in Period): Semaglutide 2.4 mg
Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg.
0
96
2
96
69
96
EG004
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
0
47
2
47
36
47
EG005
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
0
8
0
8
7
8
EG006
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
0
28
0
28
16
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected96 at risk
EG0041 events1 affected47 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected28 at risk
Tooth Abscess
Infections and infestations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25
Systematic Assessment
EG0007 events7 affected8 at risk
EG0017 events7 affected8 at risk
EG0026 events6 affected8 at risk
EG0035 events5 affected96 at risk
EG0042 events2 affected47 at risk
EG0052 events2 affected8 at risk
EG0060 events0 affected28 at risk
Depressive symptom
Psychiatric disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypercalciuria
Renal and urinary disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cerumen Impaction
Ear and labyrinth disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal Tenderness
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0014 events4 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Chest Pain
General disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Early Satiety
General disorders
MedDRA 25
Systematic Assessment
EG0003 events3 affected8 at risk
EG0012 events2 affected8 at risk
EG0024 events4 affected8 at risk
EG003
Injection Site Haemorrhage
General disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Injection Site Reaction
General disorders
MedDRA 25
Systematic Assessment
EG0004 events2 affected8 at risk
EG0011 events1 affected8 at risk
EG0022 events2 affected8 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Amylase Abnormal
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Glomerular Filtration Rate Abnormal
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Lipase Abnormal
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Depressed Level Of Consciousness
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Taste Disorder
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Mood Swings
Psychiatric disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Breast Cyst
Reproductive system and breast disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hot Flush
Vascular disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0004 events3 affected8 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0013 events3 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0005 events4 affected8 at risk
EG0019 events7 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0006 events3 affected8 at risk
EG0018 events6 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Transient lingual papillitis
Gastrointestinal disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Medication error
Injury, poisoning and procedural complications
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Amylase increased
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Lipase increased
Investigations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0022 events1 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 25
Systematic Assessment
EG0002 events1 affected8 at risk
EG0015 events5 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Injection site erythema
General disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Peripheral swelling
General disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Sensation of foreign body
General disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pyuria
Infections and infestations
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Breast calcifications
Reproductive system and breast disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 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.