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Will a new weight-loss drug mess with your coffee or antidepressants? a new study aims to find out.

NCT ID NCT06564441

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial looked at whether multiple doses of Survodutide, a weight-loss drug, change how the body absorbs and processes three common drugs: bupropion (an antidepressant), caffeine, and midazolam (a sedative). Thirty-four otherwise healthy adults with overweight or obesity took these drugs alone and then again while on Survodutide. Researchers measured drug levels in the blood to see if Survodutide interferes with them. The goal is to understand potential drug interactions for future safe use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Survodutide (also known as BI 456906), bupropion, caffeine, midazolam
What this could lead to
If successful, this study could help doctors understand whether Survodutide changes how other drugs work in the body, guiding safer use in people with overweight or obesity.
What could go wrong
This is an early Phase 1 trial with only 34 participants, so results may not apply to everyone. The study focuses on drug interactions, not on treating obesity or related conditions.

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

34 people

The number who actually took part.

Started

Oct 2024

Finished

Jan 2026

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 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 60 years (inclusive) at signing of informed consent 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 International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial, i.e. prior to starting any screening procedures legislation prior to admission to the trial, i.e. prior to starting any screening procedures 5. Further inclusion criteria apply 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-Glutamyl-Transferase (GGT) above ULN + 20%, * Lipase or amylase above ULN + 20%, * Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m². 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • SGS Life Science Services - Clinical Research

    Edegem, 2650, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.