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Recruiting NCT07693231

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

Phase I Interventional Healthy Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BI 3034701, Placebo.
Who it may be relevant to
Registry conditions: Healthy, Obesity. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • Drug BI 3034701
    BI 3034701
  • Drug Placebo
    Placebo

Primary outcome measures

  • Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator [Time frame: Part 1: up to Week 19, Part 2: up to Week 10]
Secondary outcome measures (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 [Time frame: 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 [Time frame: 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) [Time frame: Part 1: at Baseline and at Week 16]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Further exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Japan · 3 centers
  • SOUSEIKAI Hakata Clinic — Fukuoka, Fukuoka
  • Fukuoka Mirai Hospital — Fukuoka, Fukuoka
  • SOUSEIKAI Sumida Hospital — Tokyo, Sumida-ku

Identifiers

NCT: NCT07693231 · 1507-0004 · U1111-1334-2043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗