GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 1

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

An Active-comparator-controlled, Open-label, Parallel Group Study to Evaluate the Effect of Survodutide on Energy Expenditure and Fatty Acid Oxidation in Subjects With Obesity

Lead sponsor

Boehringer Ingelheim

Assets

Semaglutide / Survodutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-45

Primary endpoint

•Sleeping metabolic rate (SMR) from baseline to first visit a participant

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06745284

Org study ID1404-0045

Secondary IDU1111-1309-3679WHO register - International Clinical Trials Registry Platform (ICTRP)

Timeline

Milestones

Study first posted2024-12-20actual

Study start2025-03-26actual

Last update posted2026-05-12actual

Primary completion2027-01-08estimated

Study completion2027-01-10estimated

Assets

Investigational agents

Semaglutide Survodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.