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NCT07514260PHASE1RecruitingAccepts Healthy Volunteers

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

AbbVie

Start Date

3/31/2026

Completion Date

1/1/2027

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 Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Japanese participant must be first-or second-generation Japanese of full Japanese parentage. 1. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. 2. 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 Criteria: * 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.

Interventions

DRUG

ABBV-295

DRUG

Placebo for ABBV-295

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Conditions

Healthy Volunteer

Locations

CenExel ACT- Anaheim Clinical Trials /ID# 280879

Anaheim, California 92801

United States