A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
Completed · Phase 3 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT05646706
- Run by
- Novo Nordisk A/S
- People needed
- 1407
- Starts
- 2023-01-04
- Expected to finish
- 2024-11-26
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Univ of Alabama Birmingham — Birmingham, Alabama, United States
- Chambliss Clinical Trials, LLC — Montgomery, 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
- AMC Community Endocrinology — Albany, New York, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- PharmQuest Life Sciences LLC — Greensboro, North Carolina, United States
- Medical University Of South Carolina — Charleston, South Carolina, United States
- Amarillo Med Spec LLP — Amarillo, Texas, United States
- Elligo Clin Res Centre — Austin, Texas, United States
- Velocity Clin Res, Dallas — Dallas, Texas, United States
- UT Southwestern Medical Center-CRU — Dallas, Texas, United States
- DCOL Ctr for Clin Res — Longview, Texas, United States
- Sugar Lakes Family Practice PA — Sugar Land, Texas, United States
- National Clin Res Inc. — Richmond, Virginia, United States
- Selma Medical Associates — Winchester, Virginia, United States
- Medical centre Zdrave 1 OOD — Kozloduy, Bulgaria
- Medical center Hippocrates Lukovit EOOD — Lukovit, Bulgaria
- IPMC - Dr. Elizabeta Dimitrova — Petrich, Bulgaria
- Dom srdca, s.r.o. — Žilina, Slovakia
Full record on ClinicalTrials.gov
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