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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07514260

Enrollment

Registered

2026-04-07

Start date

2026-03-31

Completion date

2027-01-01

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, ABBV-295

Brief 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.

Interventions

DRUGABBV-295

Subcutaneous Injections

DRUGPlacebo for ABBV-295

Subcutaneous Injections

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events (AEs)	Up to approximately 138 days	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Countries

United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026