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

November 5, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • CenExel Act- Anaheim Clinical Trials /ID# 280879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese participant must be first-or second-or third-generation Japanese of full Japanese parentage.

    1. First-generation participants must have two parents and four grandparents of full Japanese descent.
    2. Second-or third-generation participants born outside of Japan must have two parents and four grandparents of full Japanese descent.

  • BMI is ≥ 25.0 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-(GLP-1) agonists, GLP-1/glucose-dependent insulinotropic polypeptide (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-295 Part 1

Participants will receive subcutaneous doses of ABBV-295 for 12 weeks.
Drug: ABBV-295

Subcutaneous Injections
Experimental: Placebo for ABBV-295 Part 1

Participants will receive subcutaneous doses of placebo for 12 weeks.
Drug: Placebo for ABBV-295

Subcutaneous Injections
Experimental: ABBV-295 Part 2

Participants will receive subcutaneous doses of ABBV-295 for 13 weeks.
Drug: ABBV-295

Subcutaneous Injections
Experimental: Placebo for ABBV-295 Part 2

Participants will receive subcutaneous doses of placebo for 13 weeks.
Drug: Placebo for ABBV-295

Subcutaneous Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 145 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.
Up to approximately 145 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M26-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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