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

Status

Completed

Phase

Phase 3

Enrollment

1,407 participants (actual)

Sponsor

Novo Nordisk A/S · Industry

Design

Randomized · Quadruple masking

Countries

12 countries

United States, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, Norway, Poland, Portugal, Slovakia, South Africa

Start

4 Jan 2023

Primary completion

30 Oct 2024

Completion

26 Nov 2024

First posted

12 Dec 2022

Last update posted

23 Apr 2026

Conditions

Obesity

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.

• 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.

• 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.

• Placebo comparator

  Placebo

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

1. Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight

   Time frame · Baseline (week 0), End of treatment (week 72)

   Registry description

   Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

2. Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)

   Time frame · At week 72

   Registry description

   Number of participants who achieve body weight reduction \>=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=5% and "no" defines participants who did not achieve body weight reduction \>=5%.