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

NCT07514260

Active Not RecruitingPhase 1

Sponsor: AbbVie

Conditions: Healthy Volunteer

Interventions: ABBV-295, Placebo for ABBV-295

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Anaheim, California, United States