RecruitingPhase 1NCT07693231

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

A Phase I, Single-blinded, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Participants With Obesity/Overweight and Otherwise Healthy (Part 1) and Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Healthy Volunteers (Part 2)


Sponsor

Boehringer Ingelheim

Enrollment

48 participants

Start Date

Jul 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Part 1: To investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 3034701 in Japanese male and female participants with body mass index (BMI) ≥27.0 kg/m² or more following subcutaneous administration of multiple rising doses over 16 weeks. Part 2: To investigate safety, tolerability, and PK of BI 3034701 in Japanese male and female healthy participants with BMI ≥23.0 to \<27.0 kg/m² following subcutaneous administration of multiple rising doses over 7 weeks.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BI 3034701 and a drug called Placebo for people with healthy and obesity. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBI 3034701

BI 3034701

DRUGPlacebo

Placebo


Locations(3)

SOUSEIKAI Hakata Clinic

Fukuoka, Fukuoka, Japan

Fukuoka Mirai Hospital

Fukuoka, Fukuoka, Japan

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, Japan

View Full Details on ClinicalTrials.gov

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NCT07693231


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