A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity

Healthy Clinical Trial

Official title:

Safety, Tolerability and Pharmacokinetics of Single Subcutaneous Doses of BI 3034701 in Healthy Male Volunteers (Part A) and of Multiple Rising Subcutaneous Doses in Otherwise Healthy Male and Female Volunteers With Obesity/Overweight (Part B)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352437
• Other study ID #: 1507-0001
• Secondary ID: 2023-508767-79-0
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2024
• Est. completion date: October 13, 2025

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.

The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.

Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.

Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 6 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: October 13, 2025
• Est. primary completion date: October 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Part A: healthy male 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.

Part B: 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 (BP, PR), 12-lead ECG, and clinical laboratory tests.

2. Part A: age of 18 to 55 years (inclusive). Part B: age 18 to 65 years (inclusive).

3. Parts A and B: Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

4. 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%

• Bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome)

• 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.

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

Drug:
• BI 3034701
BI 3034701
• Placebo matching BI 3034701
Placebo matching BI 3034701

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator		up to 48 days for Part A and up to 158 days for Part B.
Secondary	Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8) following a single dose of BI 3034701		up to 48 days.
Secondary	Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701		up to 48 days.
Secondary	Part B: Area under the concentration-time curve in plasma over the time interval from 0 to 168 hours (AUC0-168) following multiple doses of BI 3034701		up to 158 days.
Secondary	Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701		up to 158 days.

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