Heart check for new Weight-Loss drug: survodutide under scrutiny
NCT ID NCT06200467
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study checks whether survodutide, a new weight-loss injection, affects heart rhythm in 110 overweight or obese adults. Participants receive survodutide or placebo for about 30 weeks, with heart tests before and after. The goal is to see if the drug is safe for the heart, not to measure weight loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- survodutide (BI 456906)
- What this could lead to
- If it works, this could help ensure that survodutide is safe for the heart, supporting its development as a weight-loss treatment.
- What could go wrong
- This is an early Phase 1 safety study, not designed to prove weight loss. The results may not predict real-world outcomes, and heart effects are still possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
110 people
The number who actually took part.
- Started
-
Mar 2024
- Finished
-
Oct 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Otherwise healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests 2. Age of 18 to 55 years (inclusive) 3. Body mass index (BMI) of 27.0 to 39.9 kg/m2 (inclusive) and body weight \> 70 kg 4. Signed and dated written informed consent in accordance with the 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 5. Female subjects who meet any of the following criteria for a highly effective contraception from at least 7 days before the first administration of trial medication until 28 days after trial completion: * Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal). In case of oral contraception a barrier method should be used in addition. * Use of progestogen-only hormonal contraception that inhibits ovulation (oral, injectable or implantable). In case of oral contraception a barrier method should be used in addition. * Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) * Sexually abstinent * A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant * Surgically sterilised (including hysterectomy) * Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle Stimulating Hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory) Exclusion Criteria: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular: * Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20% * Aspartate aminotransferase (AST) above ULN + 20% * Gamma glutamyltransferase (GGT) above ULN + 20% * Lipase or amylase above ULN + 20% * Bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome) * eGFR \< 60 mL/min/1.73 m² 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. History of either chronic or acute pancreatitis 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Obesity are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which exercise dose best helps kids with metabolic syndrome?
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?