A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity

Phase 1

Recruiting

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

• Registration Number: NCT06745284
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-20
• Study Start: 2025-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-05-29
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Survodutide arm	Survodutide	-
Semaglutide arm	Semaglutide	-

Primary Outcome Measures

Name	Time	Method
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	at baseline, up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
Relative change in SMR (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss	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	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	at baseline, up to 36 weeks

Trial Locations

Locations (2)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States