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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: Semaglutide

• Registration Number: NCT05646706
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Study Start: 2023-01-04
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1407

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.
Semaglutide 7.2 mg	Semaglutide	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.
Semaglutide 2.4 mg	Semaglutide	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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: 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: 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: 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: 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 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 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 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 lean body 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 (%)	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 (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 (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 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 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 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 adverse events (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 AEs	From baseline (week 0) to end of study (week 81)	Measured as count of events.
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 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 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: 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: 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: 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 serious adverse events (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 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).

Trial Locations

Locations (100)

Unidade Local De Saude De Matosinhos E.P.E.; 🇵🇹 Senhora Da Hora, Matosinhos, Matosinhos, Portugal

Unidade Local de Saude de Sao Joao E.P.E; 🇵🇹 Porto, Portugal

Univ of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Healthscan Clinical Trials,LLC.; 🇺🇸 Montgomery, Alabama, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Jacksonville Ctr For Clin Res; 🇺🇸 Jacksonville, Florida, United States

Florida Inst For Clin Res LLC; 🇺🇸 Orlando, Florida, United States

Florida Institute For Clinical Research LLC; 🇺🇸 Orlando, Florida, United States

East West Med Res Inst; 🇺🇸 Honolulu, Hawaii, United States

Midwest Inst For Clin Res; 🇺🇸 Indianapolis, Indiana, United States

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