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Trial · Interventional

Active, not recruitingPhase 1Registry data

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

NCTNCT06745284 (opens ClinicalTrials.gov in a new tab)Other id1404-0045Other idU1111-1309-3679

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
2025202620272028
  1. Ph 1

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

    NCT06745284

    26 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.

  1. 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)
  1. 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

  2. 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

  3. 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
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.

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