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

NCT ID: NCT06564441

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-01-05

Brief Summary

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Survodutide

Intervention Type: DRUG

Survodutide

Bupropion

Intervention Type: DRUG

Bupropion

Caffeine

Intervention Type: DRUG

Caffeine

Midazolam

Intervention Type: DRUG

Midazolam

Interventions

Survodutide

Survodutide

Intervention Type: DRUG

Bupropion

Bupropion

Intervention Type: DRUG

Caffeine

Caffeine

Intervention Type: DRUG

Midazolam

Midazolam

Intervention Type: DRUG

Other Intervention Names

BI 456906; Wellbutrin® XR; Coffeinum® N; Midazolam Accord®

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SGS Life Science Services - Clinical Research

Edegem, , Belgium

Countries

Belgium

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2024-512332-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1307-0132

Identifier Type: REGISTRY

Identifier Source: secondary_id

1404-0008

Identifier Type: -

Identifier Source: org_study_id