A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05646706

Collaborator

(none)

1,400

Enrollment

107

Locations

Arms

23.7

Anticipated Duration (Months)

13.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look at how much weight participants will lose 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. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Semaglutide Drug: Semaglutide Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1400 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

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 was 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 was 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 was 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 was 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 was 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 was 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 was 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 was 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: Number of participants who achieve body weight reduction >=25% (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 Semaglutide 2.4 mg: Relative change in body weight [From baseline (week 0) to end of treatment (week 72)]
Measured in percentage (%).
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: 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 Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (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 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 kilogram per square meter (kg/m^2).
Semaglutide 7.2 mg versus Placebo: Change in total fat mass (%) [From baseline (week 0) to end of treatment (week 72)]
Measured in percentage (%).
Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters) [From baseline (week 0) to end of treatment (week 72)]
Measured in liters.
Semaglutide 7.2 mg versus Placebo: Change in lean body mass (%) [From baseline (week 0) to end of treatment (week 72)]
Measured in percentage (%).
Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters) [From baseline (week 0) to end of treatment (week 72)]
Measured in liters.
Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (%) [From baseline (week 0) to end of treatment (week 72)]
Measured in percentage (%).
Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters) [From baseline (week 0) to end of treatment (week 72)]
Measured in liters.
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: Number of participants with change in lipid-lowering treatment (decrease, no change, increase) [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 change in antihypertensive treatment (decrease, no change, increase) [From baseline (week 0) to end of treatment (week 72)]
Measured as count of participants.
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 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 change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D]) [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 (bmp).
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.

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.
Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2).
History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
History of type 1 or type 2 diabetes.
Treatment with glucose-lowering agent(s) within 90 days before screening.
A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35294
2	Novo Nordisk Investigational Site	Montgomery	Alabama	United States	36106
3	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
4	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
5	Novo Nordisk Investigational Site	Orlando	Florida	United States	32825
6	Novo Nordisk Investigational Site	Orlando	Florida	United States	32825
7	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
8	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
9	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46260
10	Novo Nordisk Investigational Site	Albany	New York	United States	12203
11	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27514
12	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
13	Novo Nordisk Investigational Site	Charleston	South Carolina	United States	29425
14	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
15	Novo Nordisk Investigational Site	Austin	Texas	United States	78738
16	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
17	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390
18	Novo Nordisk Investigational Site	Longview	Texas	United States	75605
19	Novo Nordisk Investigational Site	Sugar Land	Texas	United States	77479
20	Novo Nordisk Investigational Site	Richmond	Virginia	United States	23294
21	Novo Nordisk Investigational Site	Winchester	Virginia	United States	22601-3834
22	Novo Nordisk Investigational Site	Kozloduy		Bulgaria	3320
23	Novo Nordisk Investigational Site	Lukovit		Bulgaria	5770
24	Novo Nordisk Investigational Site	Petrich		Bulgaria	2850
25	Novo Nordisk Investigational Site	Smolyan		Bulgaria	4700
26	Novo Nordisk Investigational Site	Sofia		Bulgaria	1202
27	Novo Nordisk Investigational Site	Sofia		Bulgaria	1330
28	Novo Nordisk Investigational Site	Sofia		Bulgaria	1407
29	Novo Nordisk Investigational Site	Sofia		Bulgaria	1618
30	Novo Nordisk Investigational Site	Varna		Bulgaria	9000
31	Novo Nordisk Investigational Site	Varna		Bulgaria	9010
32	Novo Nordisk Investigational Site	Surrey	British Columbia	Canada	V3Z 2N6
33	Novo Nordisk Investigational Site	Surrey	British Columbia	Canada	V3Z 2N6
34	Novo Nordisk Investigational Site	Halifax	Nova Scotia	Canada	B3H 1V7
35	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
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	Hamilton	Ontario	Canada	L8M 1K7
39	Novo Nordisk Investigational Site	London	Ontario	Canada	N5W 6A2
40	Novo Nordisk Investigational Site	Benátky Na Jizerou		Czechia	29471
41	Novo Nordisk Investigational Site	Broumov		Czechia	550 01
42	Novo Nordisk Investigational Site	Praha 10		Czechia	10034
43	Novo Nordisk Investigational Site	Praha 4		Czechia	140 00
44	Novo Nordisk Investigational Site	Praha 4		Czechia	14021
45	Novo Nordisk Investigational Site	Praha 4		Czechia	149 00
46	Novo Nordisk Investigational Site	Praha		Czechia	160 00
47	Novo Nordisk Investigational Site	Berlin		Germany	13597
48	Novo Nordisk Investigational Site	Elsterwerda		Germany	04910
49	Novo Nordisk Investigational Site	Essen		Germany	45136
50	Novo Nordisk Investigational Site	Essen		Germany	45219
51	Novo Nordisk Investigational Site	Falkensee		Germany	14612
52	Novo Nordisk Investigational Site	Münster		Germany	48153
53	Novo Nordisk Investigational Site	Oldenburg I. Holst		Germany	23758
54	Novo Nordisk Investigational Site	Rehlingen-Siersburg		Germany	66780
55	Novo Nordisk Investigational Site	Wangen		Germany	88239
56	Novo Nordisk Investigational Site	Witten		Germany	58455
57	Novo Nordisk Investigational Site	Athens		Greece	GR-11527
58	Novo Nordisk Investigational Site	Athens		Greece	GR-15125
59	Novo Nordisk Investigational Site	Athens		Greece	GR-17562
60	Novo Nordisk Investigational Site	Haidari-Athens		Greece	GR-12462
61	Novo Nordisk Investigational Site	Lamia		Greece	GR35100
62	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54635
63	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54636
64	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54642
65	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-57001
66	Novo Nordisk Investigational Site	Baja		Hungary	6500
67	Novo Nordisk Investigational Site	Budapest		Hungary	1089
68	Novo Nordisk Investigational Site	Budapest		Hungary	1106
69	Novo Nordisk Investigational Site	Budapest		Hungary	1132
70	Novo Nordisk Investigational Site	Debrecen		Hungary	4025
71	Novo Nordisk Investigational Site	Nyíregyháza		Hungary	4405
72	Novo Nordisk Investigational Site	Székesfehérvár		Hungary	8000
73	Novo Nordisk Investigational Site	Hamar		Norway	2317
74	Novo Nordisk Investigational Site	Oslo		Norway	0373
75	Novo Nordisk Investigational Site	Tønsberg		Norway	3116
76	Novo Nordisk Investigational Site	Lublin	Lubelskie	Poland	20-044
77	Novo Nordisk Investigational Site	Lublin	Lubelski	Poland	20-538
78	Novo Nordisk Investigational Site	Krakow	Malopolskie	Poland	31-261
79	Novo Nordisk Investigational Site	Warsaw	Mazowieckie	Poland	00-465
80	Novo Nordisk Investigational Site	Warszawa	Mazowieckie	Poland	02-507
81	Novo Nordisk Investigational Site	Bialystok	Podlaskie	Poland	15-481
82	Novo Nordisk Investigational Site	Gdynia	Pomorskie	Poland	81-338
83	Novo Nordisk Investigational Site	Katowice		Poland	40-752
84	Novo Nordisk Investigational Site	Lisboa		Portugal	1250-230
85	Novo Nordisk Investigational Site	Lisboa		Portugal	1349-019
86	Novo Nordisk Investigational Site	Lisboa		Portugal	1500-650
87	Novo Nordisk Investigational Site	Matosinhos		Portugal	4464-513
88	Novo Nordisk Investigational Site	Porto		Portugal	4200-319
89	Novo Nordisk Investigational Site	Vila Nova de Gaia		Portugal	4400-346
90	Novo Nordisk Investigational Site	Bratislava		Slovakia	821 01
91	Novo Nordisk Investigational Site	Bratislava		Slovakia	842 31
92	Novo Nordisk Investigational Site	Lucenec		Slovakia	984 01
93	Novo Nordisk Investigational Site	Malacky		Slovakia	901 01
94	Novo Nordisk Investigational Site	Martin		Slovakia	036 01
95	Novo Nordisk Investigational Site	Presov		Slovakia	080 01
96	Novo Nordisk Investigational Site	Zilina		Slovakia	010 01
97	Novo Nordisk Investigational Site	Zilina		Slovakia	01001
98	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape	South Africa	6001
99	Novo Nordisk Investigational Site	Bloemfontein	Free State	South Africa	9301
100	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1818
101	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1827
102	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1829
103	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2013
104	Novo Nordisk Investigational Site	Durban	KwaZulu Natal	South Africa	4093
105	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4001
106	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4092
107	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:

NCT05646706

Other Study ID Numbers:

NN9536-4999
U1111-1274-4259
2022-000790-94

First Posted:

Dec 12, 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:

Obesity

Study Results

No Results Posted as of Jan 25, 2023