A Research Study to Look Into How Well Semaglutide Medici... | NCT05486065

ID	Type	Description	Link
U1111-1271-9209	Other Identifier	World Health Organization (WHO)
2022-000882-41	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semaglutide 2 mg	Experimental	Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.	Drug: Semaglutide
Semaglutide placebo 2 mg	Placebo Comparator	Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.	Drug: Placebo
Semaglutide 8 mg	Experimental	Participants will receive once-weekly semaglutide 8 mg s.c. injection.	Drug: Semaglutide
Semaglutide placebo 8 mg	Placebo Comparator	Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.	Drug: Placebo
Semaglutide 16 mg	Experimental	Participants will receive once-weekly semaglutide 16 mg s.c. injection.	Drug: Semaglutide
Semaglutide placebo 16 mg	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.	Semaglutide 16 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.	Baseline (week 0) and End of treatment (week 40)

Secondary Outcomes

Measure	Description	Time Frame
Change in Body Weight	Change in body weight from baseline (week 0) to end of treatment (week 40) is presented.	Baseline (week 0) and End of treatment (week 40)
Number of Treatment-emergent Adverse Events (TEAEs)

Eligibility Module

Name	Affiliation	Role
Clinical Transparency (dept. 2834)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univ of Alabama Birmingham		Birmingham	Alabama	35294	United States
University of Alabama Birmingham

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Semaglutide 2.0 mg	Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.
FG001	Semaglutide 8.0 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 3, 2023	Oct 10, 2024

An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable & unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period data are presented. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for participants that are lost to follow up.

Arm/Group Information

ID	Title	Description
BG000	Semaglutide 2.0 mg	Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.
BG001	Semaglutide 8.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.
BG002	Semaglutide 16.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.
BG003	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
BG004	Total	Total of all reporting groups

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
	BG00052.3± 7.6 BG00153.7± 7.5 BG00252.9± 8.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00133 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG0018 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

Change in Glycated Haemoglobin (HbA1c)

Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.

Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

Percentage-point of HbA1c

Baseline (week 0) and End of treatment (week 40)

ID	Title	Description
OG000	Semaglutide 2.0 mg	Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.
OG001	Semaglutide 8.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.
OG002	Semaglutide 16.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.
OG003	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

Units	Counts
Participants	OG00056 OG00157 OG00256 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-1.9± 1.1 OG001-1.8± 1.5 OG002-2.1± 1.5 OG003

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 OG003		ANCOVA		0.0002		Treatment difference	-0.82			2-Sided	95	-1.25	-0.39					Superiority	The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.
OG001

Secondary

Change in Body Weight

Change in body weight from baseline (week 0) to end of treatment (week 40) is presented.

Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

Kilogram (kg)

Baseline (week 0) and End of treatment (week 40)

ID	Title	Description
OG000	Semaglutide 2.0 mg	Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.
OG001	Semaglutide 8.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.
OG002	Semaglutide 16.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

Secondary

Number of Treatment-emergent Adverse Events (TEAEs)

Safety analysis set included all participants who are exposed to randomised treatment.

Posted

Number

Events

From baseline (week 0) up to end of study (week 49)

ID	Title	Description
OG000	Semaglutide 2.0 mg	Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.
OG001	Semaglutide 8.0 mg

Secondary

Number of Treatment-emergent Severe Hypoglycaemic Episodes

Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for participants that are lost to follow up.

Safety analysis set included all participants who are exposed to randomised treatment.

Posted

Number

Episodes

From baseline (week 0) up to end of study (week 49)

ID	Title	Description
OG000	Semaglutide 2.0 mg	Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.
OG001	Semaglutide 8.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Semaglutide 2.0 mg	Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.	60	4	60	30	60
EG001	Semaglutide 8.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.	60	2	60	48	60
EG002	Semaglutide 16.0 mg	Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.	62	1	62	50	62
EG003	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.	59	2	59	29	59

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure chronic	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected60 at risk EG0020 events0 affected62 at risk EG0030 events0 affected59 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected60 at risk EG0021 events1 affected62 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0010 events0 affected60 at risk EG0020 events0 affected62 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected60 at risk EG0020 events0 affected62 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0010 events0 affected60 at risk EG0020 events0 affected62 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected60 at risk EG0020 events0 affected62 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0010 events0 affected60 at risk EG0020 events0 affected62 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected60 at risk EG0020 events0 affected62 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0010 events0 affected60 at risk EG0020 events0 affected62 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected60 at risk EG0014 events4 affected60 at risk EG0023 events3 affected62 at risk EG0031 events1 affected59 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected60 at risk EG0011 events1 affected60 at risk EG0024 events4 affected62 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected60 at risk EG0016 events5 affected60 at risk EG0023 events2 affected62 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0010 events0 affected60 at risk EG0027 events6 affected62 at risk EG003
COVID-19	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0018 events8 affected60 at risk EG0021 events1 affected62 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected60 at risk EG00111 events8 affected60 at risk EG00216 events12 affected62 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected60 at risk EG0022 events2 affected62 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00029 events9 affected60 at risk EG00130 events20 affected60 at risk EG00219 events13 affected62 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected60 at risk EG0016 events6 affected60 at risk EG0023 events3 affected62 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected60 at risk EG0012 events2 affected60 at risk EG0020 events0 affected62 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0013 events3 affected60 at risk EG0022 events2 affected62 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected60 at risk EG0015 events5 affected60 at risk EG00213 events5 affected62 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected60 at risk EG0013 events3 affected60 at risk EG0028 events5 affected62 at risk EG003
Fatigue	General disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected60 at risk EG0014 events4 affected60 at risk EG0027 events6 affected62 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected60 at risk EG0013 events3 affected60 at risk EG0021 events1 affected62 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0014 events4 affected60 at risk EG0023 events3 affected62 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected60 at risk EG0020 events0 affected62 at risk EG003
Headache	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0006 events2 affected60 at risk EG00113 events6 affected60 at risk EG0029 events7 affected62 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected60 at risk EG0026 events5 affected62 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected60 at risk EG0020 events0 affected62 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected60 at risk EG0020 events0 affected62 at risk EG003
Hypertension	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0013 events3 affected60 at risk EG0020 events0 affected62 at risk EG003
Lipase increased	Investigations	MedDRA 26	Systematic Assessment	EG0003 events3 affected60 at risk EG0012 events2 affected60 at risk EG0023 events3 affected62 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0004 events3 affected60 at risk EG0011 events1 affected60 at risk EG0023 events3 affected62 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00017 events13 affected60 at risk EG00154 events25 affected60 at risk EG00229 events23 affected62 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected60 at risk EG0025 events5 affected62 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected60 at risk EG0011 events1 affected60 at risk EG0025 events5 affected62 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00016 events11 affected60 at risk EG00126 events14 affected60 at risk EG00232 events16 affected62 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases