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A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Japanese Healthy People and Japanese People With Obesity or Overweight
Sponsor: Boehringer Ingelheim
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-07-30
Completion Date
2027-01-29
Last Updated
2026-07-09
Healthy Volunteers
Yes
Interventions
BI 3034701
BI 3034701
Placebo
Placebo
Locations (3)
SOUSEIKAI Hakata Clinic
Fukuoka, Fukuoka, Japan
Fukuoka Mirai Hospital
Fukuoka, Fukuoka, Japan
SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, Japan