Testing how well different doses of BI 3034701 are tolerated in healthy men and people with overweight or obesity

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)

This study is testing how well different doses of a new drug called BI 3034701 are tolerated by healthy men and people with overweight or obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Berlin)
• Trial ID: NCT06352437 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the tolerance of various doses of BI 3034701 in two groups: healthy men aged 18 to 55 and individuals aged 18 to 65 with overweight or obesity. The study consists of two parts, with Part A involving a single dose for healthy men and Part B administering multiple doses to participants with overweight or obesity. Participants receive either BI 3034701 or a placebo via subcutaneous injection, and the study aims to assess both tolerance and blood absorption of the drug. This is the first time BI 3034701 is being tested in humans.

Who should consider this trial

Good fit: Ideal candidates include healthy men aged 18 to 55 and individuals aged 18 to 65 with overweight or obesity who meet specific health criteria.

Not a fit: Patients with significant health issues or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of the safety and tolerability of BI 3034701, potentially paving the way for new treatments for obesity.

How similar studies have performed: While this specific approach is novel as it involves the first human testing of BI 3034701, similar studies assessing drug tolerance have shown success in the past.

Eligibility criteria

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.

Where this trial is running

Berlin

• Charité Research Organisation GmbH — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy