Current partner codePEPTIDESDE
NCT06745284·Phase 1·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 1

Enrollment

64

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Survodutide

Survodutide

DRUG

Semaglutide

Semaglutide

Timeline

From registration to results.

  1. First posted

    Dec 20, 2024

  2. Study start

    Mar 26, 2025

  3. Primary completion

    Jan 8, 2027

  4. Study completion

    Jan 10, 2027

  5. Results posted

    Not reported

  6. Registry updated

    May 12, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion criteria * Age of 18 to 65 years (inclusive) * Male or female subjects with obesity (defined as a body mass index (BMI) of ≥30 and ≤45 kg/m²) * Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information * Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * In the investigator's opinion, are well-motivated, capable, and willing to: * Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP) * Inject the IMP or accept injection from a designated person --- Follow trial procedures for the duration of the trial, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise, maintain a diary, complete required questionnaires, and handle the IMP as described in the instruction for use (IFU)) Exclusion criteria: * Current or history of significant alcohol consumption (defined as intake of \>210 g/week in men and \>140 g/week in women on average over a consecutive period of more than 3 months) or are unwilling to stop alcohol consumption 48 h before admission to the research facility and until discharge * History of chronic liver disease / cirrhosis * Body weight variation (self-reported) \>5% within 3 months before Visit 1 (screening) * Medications for obesity (including over-the-counter medications) within 3 months before Visit 1 (screening) * Glycated haemoglobin (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the local laboratory at screening * History of type 1 diabetes mellitus (T1DM) or T2DM or treatment with glucose lowering agent started within 3 months before Visit 1 (screening) Further exclusion criteria apply.

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

AdventHealth - Translation Research Institute

Orlando, Florida, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.