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

NCT07693231 | Recruiting Phase 1

• 2 other identifiers: 1507-0004U1111-1334-2043
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Healthy; Obesity

Outcome Measures

Primary Outcomes (1)

• Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  Expressed as the percentage of trial participants treated with investigational drug who experience such an event

  Part 1: up to Week 19, Part 2: up to Week 10

Secondary Outcomes (3)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) following a single dose and multiple doses of BI 3034701

  Part 1: up to Week 17, Part 2: up to Week 8

• Maximum measured concentration of the analyte in plasma (Cmax) following a single dose and multiple doses of BI 3034701

  Part 1: up to Week 19, Part 2: up to Week 10

• Change from baseline in body weight at the end of 16 weeks treatment (only evaluated for Part 1)

  Part 1: at Baseline and at Week 16

Study Arms (2)

BI 3034701

EXPERIMENTAL

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

Drug: BI 3034701

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BI 3034701 DRUG

BI 3034701

BI 3034701

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 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
• 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
• Part 1: Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (3)

SOUSEIKAI Hakata Clinic

Fukuoka, Fukuoka, 812-0025, Japan

RECRUITING

Fukuoka Mirai Hospital

Fukuoka, Fukuoka, 813-0017, Japan

RECRUITING

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 130-0004, Japan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): January 5, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)