A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05649137

Collaborator

(none)

500

Enrollment

Locations

Arms

23.7

Anticipated Duration (Months)

6.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus, Type 2	Drug: Semaglutide Drug: Semaglutide Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes

Actual Study Start Date :

Jan 4, 2023

Anticipated Primary Completion Date :

Oct 23, 2024

Anticipated Study Completion Date :

Dec 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide 7.2 mg Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.	Drug: Semaglutide Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Experimental: Semaglutide 2.4 mg Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.	Drug: Semaglutide Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Placebo Comparator: Placebo Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.	Drug: Placebo Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Arm

Intervention/Treatment

Experimental: Semaglutide 7.2 mg

Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.

Drug: Semaglutide

Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Experimental: Semaglutide 2.4 mg

Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.

Drug: Semaglutide

Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Placebo Comparator: Placebo

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.

Drug: Placebo

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Outcome Measures

Primary Outcome Measures

Semaglutide 7.2 mg versus Placebo: Relative change in body weight [From baseline (week 0) to end of treatment (week 72)]
Measured in percentage (%).
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no) [From baseline (week 0) to end of treatment (week 72)]
Measured as count of participants.

Secondary Outcome Measures

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no) [From baseline (week 0) to end of treatment (week 72)]
Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no) [From baseline (week 0) to end of treatment (week 72)]
Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no) [From baseline (week 0) to end of treatment (week 72)]
Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Change in waist circumference [From baseline (week 0) to end of treatment (week 72)]
Measured in centimeters (cm).
Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 72)]
Measured in percentage (%).
Semaglutide 7.2 mg versus Placebo: Change in body weight [From baseline (week 0) to end of treatment (week 72)]
Measured in kilograms (kg).
Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI) [From baseline (week 0) to end of treatment (week 72)]
Measured in kilograms per square meter (kg/m^2).
Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure [From baseline (week 0) to end of treatment (week 72)]
Measured in millimeters of mercury (mmHg).
Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure [From baseline (week 0) to end of treatment (week 72)]
Measured in mmHg.
Semaglutide 7.2 mg versus Placebo: Change in total cholesterol [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in very-low-density lipoprotein (VLDL) cholesterol [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in triglycerides [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in free fatty acids [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP) [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose [From baseline (week 0) to end of treatment (week 72)]
Measured in milligrams per deciliter (mg/dL).
Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin [From baseline (week 0) to end of treatment (week 72)]
Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than (<) 7.0% (53 millimoles per mole [mmol/mol]) [From baseline (week 0) to end of treatment (week 72)]
Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than or equal to (<=) 6.5 % (48 mmol/mol) [From baseline (week 0) to end of treatment (week 72)]
Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs) [From baseline (week 0) to end of study (week 81)]
Measured as count of events.
Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs) [From baseline (week 0) to end of study (week 81)]
Measured as count of events.
Semaglutide 7.2 mg versus Placebo: Change in pulse [From baseline (week 0) to end of treatment (week 72)]
Measured in beats per minute (bpm).
Semaglutide 7.2 mg versus Placebo: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [From baseline (week 0) to end of study (week 81)]
Measured as count of episodes.
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs [From baseline (week 0) to end of study (week 81)]
Measured as count of events.
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs [From baseline (week 0) to end of study (week 81)]
Measured as count of events.
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [From baseline (week 0) to end of study (week 81)]
Measured as count of episodes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female.
Age above or equal to 18 years at the time of signing informed consent.
BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
History of at least one self-reported unsuccessful dietary effort to lose body weight.
HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.

Exclusion Criteria:

A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^{2) (less than 45
mL/min/1.73 m}2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
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 randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35222
2	Novo Nordisk Investigational Site	Montgomery	Alabama	United States	36106
3	Novo Nordisk Investigational Site	Concord	California	United States	94553
4	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
5	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
6	Novo Nordisk Investigational Site	Golden	Colorado	United States	80401
7	Novo Nordisk Investigational Site	DeLand	Florida	United States	32720
8	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
9	Novo Nordisk Investigational Site	Orlando	Florida	United States	32825
10	Novo Nordisk Investigational Site	Oviedo	Florida	United States	32765
11	Novo Nordisk Investigational Site	Conyers	Georgia	United States	30094
12	Novo Nordisk Investigational Site	Albany	New York	United States	12203
13	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27514
14	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
15	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
16	Novo Nordisk Investigational Site	Austin	Texas	United States	78738
17	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
18	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390
19	Novo Nordisk Investigational Site	Houston	Texas	United States	77079
20	Novo Nordisk Investigational Site	Longview	Texas	United States	75605
21	Novo Nordisk Investigational Site	Sugar Land	Texas	United States	77479
22	Novo Nordisk Investigational Site	Richmond	Virginia	United States	23294
23	Novo Nordisk Investigational Site	Winchester	Virginia	United States	22601-3834
24	Novo Nordisk Investigational Site	Blagoevgrad		Bulgaria	2700
25	Novo Nordisk Investigational Site	Burgas		Bulgaria	8000
26	Novo Nordisk Investigational Site	Dobrich		Bulgaria	9300
27	Novo Nordisk Investigational Site	Pazardzhik		Bulgaria	4400
28	Novo Nordisk Investigational Site	Plovdiv		Bulgaria	4004
29	Novo Nordisk Investigational Site	Sliven		Bulgaria	8800
30	Novo Nordisk Investigational Site	Sofia		Bulgaria	1233
31	Novo Nordisk Investigational Site	Stara Zagora		Bulgaria	6000
32	Novo Nordisk Investigational Site	Yambol		Bulgaria	8600
33	Novo Nordisk Investigational Site	Surrey	British Columbia	Canada	V3Z 2N6
34	Novo Nordisk Investigational Site	Moncton	New Brunswick	Canada	E1G 1A7
35	Novo Nordisk Investigational Site	Halifax	Nova Scotia	Canada	B3H 1V7
36	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
37	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8M 1K7
38	Novo Nordisk Investigational Site	London	Ontario	Canada	N5W 6A2
39	Novo Nordisk Investigational Site	Baja		Hungary	6500
40	Novo Nordisk Investigational Site	Budapest		Hungary	1089
41	Novo Nordisk Investigational Site	Budapest		Hungary	1106
42	Novo Nordisk Investigational Site	Budapest		Hungary	1132
43	Novo Nordisk Investigational Site	Debrecen		Hungary	4025
44	Novo Nordisk Investigational Site	Nyíregyháza		Hungary	4405
45	Novo Nordisk Investigational Site	Székesfehérvár		Hungary	8000
46	Novo Nordisk Investigational Site	Lublin	Lubelskie	Poland	20-044
47	Novo Nordisk Investigational Site	Lublin	Lubelski	Poland	20-538
48	Novo Nordisk Investigational Site	Krakow	Malopolskie	Poland	31-261
49	Novo Nordisk Investigational Site	Warsaw	Mazowieckie	Poland	00-465
50	Novo Nordisk Investigational Site	Warszawa	Mazowieckie	Poland	02-507
51	Novo Nordisk Investigational Site	Bialystok	Podlaskie	Poland	15-481
52	Novo Nordisk Investigational Site	Gdynia	Pomorskie	Poland	81-338
53	Novo Nordisk Investigational Site	Katowice		Poland	40-752
54	Novo Nordisk Investigational Site	Lisboa		Portugal	1250-230
55	Novo Nordisk Investigational Site	Lisboa		Portugal	1349-019
56	Novo Nordisk Investigational Site	Lisboa		Portugal	1500-650
57	Novo Nordisk Investigational Site	Matosinhos		Portugal	4464-513
58	Novo Nordisk Investigational Site	Porto		Portugal	4200-319
59	Novo Nordisk Investigational Site	Vila Nova de Gaia		Portugal	4400-346
60	Novo Nordisk Investigational Site	Bardejov		Slovakia	08501
61	Novo Nordisk Investigational Site	Bytca		Slovakia	014 01
62	Novo Nordisk Investigational Site	Kosice		Slovakia	04013
63	Novo Nordisk Investigational Site	Povazska Bystrica		Slovakia	01701
64	Novo Nordisk Investigational Site	Presov		Slovakia	080 01
65	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape	South Africa	6001
66	Novo Nordisk Investigational Site	Bloemfontein	Free State	South Africa	9301
67	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1818
68	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1827
69	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1829
70	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2013
71	Novo Nordisk Investigational Site	Durban	KwaZulu Natal	South Africa	4093
72	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4001
73	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4092
74	Novo Nordisk Investigational Site	Umkomaas	KwaZulu-Natal	South Africa	4170

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05649137

Other Study ID Numbers:

NN9536-7545
2022-002235-60
U1111-1279-0359

First Posted:

Dec 13, 2022

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Obesity

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 25, 2023