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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Boehringer Ingelheim
Study ID
NCT06745284
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 26, 2025
Status verified
May 2026
Primary completion
Jan 8, 2027
Completion
Jan 10, 2027

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Survodutide arm
  • Active Comparator: Semaglutide arm

Primary Outcome Measure

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
AdventHealth - Translation Research InstituteOrlandoFlorida32804-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-

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