Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
Completed · Phase 3 · Has a placebo group
Conditions studied: Overweight, Obesity
In brief
This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.
Key facts
- Study ID
- NCT05564117
- Run by
- Novo Nordisk A/S
- People needed
- 307
- Starts
- 2022-10-11
- Expected to finish
- 2024-05-07
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) of
- Greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
- Greater than or equal to 30.0 kg/m\^2
- History of at least one self-reported unsuccessful dietary effort to lose body weight
You may not qualify if…
- A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
- HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
Where it is running
- Univsty Of AL At Birmingham — Birmingham, Alabama, United States
- FDRC — Costa Mesa, California, United States
- East West Medical Research Institute_Honolulu — Honolulu, Hawaii, United States
- Accellacare — Wilmington, North Carolina, United States
- UT Southwestern Med Cntr — Dallas, Texas, United States
- Washington Cntr Weight Mgmt — Arlington, Virginia, United States
- Selma Medical Associates — Winchester, Virginia, United States
- G.A. Research Associates Ltd. — Moncton, New Brunswick, Canada
- Wharton Med Clin Trials — Hamilton, Ontario, Canada
- InnoDiab Forschung GmbH — Essen, Germany
- Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz — Lingen, Germany
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin — Münster, Germany
- RED-Institut für medizinische Forschung und Fortbildung GmbH — Oldenburg in Holstein, Germany
- Praxis Dr. med. Wenzl-Bauer — Rehlingen-Siersburg, Germany
- MZM Praxis Drs. Erlinger — Stuttgart, Germany
- Praxis für Prävention und Therapie, Drs Jacob — Villingen-Schwenningen, Germany
- Zentrum für klinische Studien Allgäu Oberschwaben — Wangen, Germany
- Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j. — Legnica, Lower Silesian Voivodeship, Poland
- ETG Lublin — Lublin, Lublin Voivodeship, Poland
- ETG Siedlce — Siedlce, Masovian Voivodeship, Poland
- ETG Warszawa Sp. z o.o. — Warsaw, Masovian Voivodeship, Poland
- Gabinet Leczenia Otylosci i Chorob Dietozaleznych — Bialystok, Podlaskie Voivodeship, Poland
- Centrum Zdrowia Metabolicznego — Poznan, Wielkopolskie Voivodeship, Poland
Full record on ClinicalTrials.gov
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