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

Last updated: May 13, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

Obesity

Hypertriglyceridemia

Treatment

Placebo matching BI 3034701

BI 3034701

Clinical Study ID

NCT06352437
1507-0001
2023-508767-79-00
U1111-1302-5933
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 5 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Part A: healthy male subjects according to the assessment of the investigator, asbased on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), andclinical laboratory tests. Part B: healthy male or female subjects according to the assessment of theinvestigator, as based on a complete medical history including a physicalexamination, 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 theInternational Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and locallegislation prior to admission to the trial.

  4. Further inclusion criteria apply

Exclusion

Exclusion Criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator.

  2. Repeated measurement of systolic blood pressure outside the range of 90 to 140millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90mmHg, 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 tobe 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

  1. Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator.

  2. Further exclusion criteria apply.

Study Design

Total Participants: 125
Treatment Group(s): 2
Primary Treatment: Placebo matching BI 3034701
Phase: 1
Study Start date:
June 10, 2024
Estimated Completion Date:
October 05, 2025

Connect with a study center

  • Charité Research Organisation GmbH

    Berlin, 10117
    Germany

    Active - Recruiting

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