RecruitingPhase 1NCT07514260

A Study to Assess Adverse Events, Tolerability, and Pharmacokinetics of Subcutaneous Injections of ABBV-295 in Healthy Adult Japanese Participants With Overweight or Obesity.

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-295 in Healthy Japanese Subjects With Overweight or Obesity

Sponsor

AbbVie

Enrollment

24 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer

Summary

The purpose of this study is to assess the adverse events, tolerability, and Pharmacokinetics (PK) of subcutaneous injections of ABBV-295 in healthy adult Japanese participants with overweight or obesity.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

Japanese participant must be first-or second-generation Japanese of full Japanese parentage.
First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent.
Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
BMI is ≥ 23.0 to ≤ 35.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.

Exclusion Criteria3

Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening.
HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening.
Participant has taken a medication for the purpose of treating obesity (e.g. Glucagon-like peptide-1, (GLP-1) agonists, Glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonists, bupropion-naltrexone, orlistat, metformin, phentermine-topiramate, amphetamine based stimulants, methylphenidate) or has been enrolled in an obesity trial within 180 days prior to study treatment administration.

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