Skip to main content
OpenTrials
Completed

NCT Number: NCT06564441

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age of 18 to 60 years (inclusive) at signing of informed consent
  • Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) and body weight > 70 kg
  • 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
  • Further inclusion criteria apply

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
  • 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)
  • 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.
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Further exclusion criteria apply

Treatment and study plan

Survodutide

Combination Product

Survodutide, pre-filled syringe

Other names: BI 456906

bupropion

Drug

Bupropion

Other names: Wellbutrin® XR

Caffeine

Drug

Caffeine

Other names: Coffeinum® N

midazolam

Drug

Midazolam

Other names: Midazolam Accord®

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Maximum measured concentration of bupropion in plasma (Cmax)

    Time frame: Up to week 32

  5. Maximum measured concentration of caffeine in plasma (Cmax)

    Time frame: Up to week 32

  6. Maximum measured concentration of midazolam in plasma (Cmax)

    Time frame: Up to week 32

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label, Non-randomised, Fixed-sequence, Two Period, Phase I Trial to Evaluate the Effect of Different Doses of BI 456906 (Survodutide) on the Single Dose Pharmacokinetics of Bupropion, Caffeine and Midazolam on Otherwise Healthy Volunteers With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.