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

NCTNCT06564441Other id1404-0008Other id2024-512332-29-00Other idU1111-1307-0132

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 34 participants (actual)
Sponsor: Boehringer Ingelheim · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Belgium
Start: 1 Oct 2024
Primary completion: 16 Dec 2025
Completion: 5 Jan 2026
First posted: 21 Aug 2024
Last update posted: 13 Mar 2026
Conditions: Overweight · Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 1
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
NCT06564441
1 Oct 2024 to 5 Jan 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

SurvodutideCombination product
BupropionDrug
CaffeineDrug
MidazolamDrug

Arms1

Experimental
All participants
In Period 1: Bupropion, Caffeine, Midazolam are given as a reference treatment. In Period 2: Survodutide, Bupropion, Caffeine, Midazolam are given as a test treatment.

Primary outcomes6

Outcomes the sponsor listed as primary.

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

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.

Completed trials do not always post results.

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 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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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