Current partner codePEPTIDESDE
NCT06564441·Phase 1·INTERVENTIONAL

A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity

Status

Completed

Phase

Phase 1

Enrollment

34

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study is open to adults with overweight or obesity who are otherwise healthy. People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion, caffeine, and midazolam in the blood. The study has 2 treatment periods. In Period 1, participants take 1 dose each of midazolam, caffeine, and bupropion as tablets or oral solution on separate days. In Period 2, participants get BI 456906 as an injection under the skin once a week. At 2 selected timepoints in Period 2, participants also take midazolam, caffeine and bupropion as tablets or oral solution on separate days. Participants are in the study for about 13 months. They visit the study site up to 45 times. At 3 of those visits, participants stay for 5 or 6 days at the study site. During the visits, doctors collect information about participants' health and take blood samples from the participants. They compare the amounts of midazolam, caffeine, and bupropion in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

Survodutide

Survodutide, pre-filled syringe

DRUG

Bupropion

Bupropion

DRUG

Caffeine

Caffeine

DRUG

Midazolam

Midazolam

Timeline

From registration to results.

  1. First posted

    Aug 21, 2024

  2. Study start

    Oct 1, 2024

  3. Primary completion

    Dec 16, 2025

  4. Study completion

    Jan 5, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 13, 2026

Outcomes

What the study measures.

Primary outcomes

Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)

Time frame · Up to week 32

Area under the concentration-time curve of the caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)

Time frame · Up to week 32

Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)

Time frame · Up to week 32

Maximum measured concentration of bupropion in plasma (Cmax)

Time frame · Up to week 32

Maximum measured concentration of caffeine in plasma (Cmax)

Time frame · Up to week 32

Maximum measured concentration of midazolam in plasma (Cmax)

Time frame · Up to week 32

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
Yes

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

Study locations

1 registered sites.

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

SGS Life Science Services - Clinical Research

Edegem, Belgium

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.