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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)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:

• Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \< 10 years, and have parents and grandparents who are Japanese

• Part 1: Male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests

• Part 2: Healthy male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests

• Parts 1 and 2: Age of 18 to 64 years (inclusive)

• Further inclusion criteria apply.

Locations
Other Locations
Japan
Fukuoka Mirai Hospital
RECRUITING
Fukuoka, Fukuoka
SOUSEIKAI Hakata Clinic
RECRUITING
Fukuoka, Fukuoka
SOUSEIKAI Sumida Hospital
RECRUITING
Tokyo, Sumida-ku
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2026-07-21
Estimated Completion Date: 2027-01-05
Participants
Target number of participants: 48
Treatments
Experimental: BI 3034701
Part 1: multiple rising doses in participants with BMI~≥27.0 kg/m² or more~Part 2: multiple rising doses in participants with BMI ≥23.0 to \<27.0 kg/m²
Placebo_comparator: Placebo
Part 1: multiple rising doses in participants with BMI~≥27.0 kg/m² or more~Part 2: multiple rising doses in participants with BMI ≥23.0 to \<27.0 kg/m²
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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