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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 3034701; Drug: Placebo matching BI 3034701

Study type: Interventional

Funder types: Industry

Identifiers

NCT06352437

1507-0001

U1111-1302-5933 (Registry Identifier)

2023-508767-79-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 14 patient groups, including a placebo group

Part A: BI 3034701 dose group 1

Experimental group

Part A: BI 3034701 dose group 2

Experimental group

Treatment:

Drug: BI 3034701

Part A: BI 3034701 dose group 3

Experimental group

Treatment:

Drug: BI 3034701

Part A: BI 3034701 dose group 4

Experimental group

Treatment:

Drug: BI 3034701

Part A: BI 3034701 dose group 5

Experimental group

Treatment:

Drug: BI 3034701

Part A: BI 3034701 dose group 6

Experimental group

Treatment:

Drug: BI 3034701

Part A: BI 3034701 dose group 7

Experimental group

Part A: BI 3034701 dose group

Experimental group

Treatment:

Drug: BI 3034701

Part A: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3034701

Part B: BI 3034701 dose group 1

Experimental group

Treatment:

Drug: BI 3034701

Part B: BI 3034701 dose group 2

Experimental group

Treatment:

Drug: BI 3034701

Part B: BI 3034701 dose group 3

Experimental group

Treatment:

Drug: BI 3034701

Part B: BI 3034701 dose group 4

Experimental group

Treatment:

Drug: BI 3034701

Part B: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3034701