Trial · Interventional
Active, not recruitingPhase 1Registry dataA Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
Overview
- Status
- Active, not recruiting
- Phase
- Phase 1
- Enrollment
- 64 participants (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 26 Mar 2025
- Primary completion
- 8 Jan 2027 (estimated)
- Completion
- 10 Jan 2027 (estimated)
- First posted
- 20 Dec 2024
- Last update posted
- 12 May 2026
- Conditions
- Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
NCT0674528426 Mar 2025 to est. 10 Jan 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is open to adults between 18 and 65 years of age who have obesity. People can join the study if they have a body mass index (BMI) between 30 and 45 km/m². The purpose of this study is to find out whether a medicine called survodutide improves how the body uses energy and breaks down fat. This study compares survodutide with another medicine called semaglutide. Survodutide is being developed to treat people with obesity. Semaglutide is already used to treat people with obesity. Participants are put into 2 groups by chance. One group gets survodutide and the other group gets semaglutide. Participants get survodutide or semaglutide as an injection under the skin once a week. Participants are in the study for 8-10 months depending on how long the treatment is given. During this time, they visit the study site weekly. Some of the visits may also be done at the participant's home instead of the study site. At some of the visits, doctors test how much energy a participant's body uses. This is done in a special room where they measure the oxygen that is breathed in and the carbon dioxide that is breathed out by the participant. The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
- SurvodutideDrug
- SemaglutideDrug
Arms2
Experimental
Survodutide arm
Active comparator
Semaglutide arm
Primary outcomes1
Outcomes the sponsor listed as primary.
Absolute change in sleeping metabolic rate (SMR) (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame · at baseline, up to 36 weeks
Secondary outcomes(3)
Relative change in SMR (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame · at baseline, up to 36 weeks
Absolute change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame · at baseline, up to 36 weeks
Relative change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame · at baseline, up to 36 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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