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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M26-009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-295

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  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 138 days

Study Arms (4)

ABBV-295 Part 1

EXPERIMENTAL

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

Drug: ABBV-295

Placebo for ABBV-295 Part 1

EXPERIMENTAL

Participants will receive subcutaneous doses of placebo for 12 weeks.

Drug: Placebo for ABBV-295

ABBV-295 Part 2

EXPERIMENTAL

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

Drug: ABBV-295

Placebo for ABBV-295 Part 2

EXPERIMENTAL

Participants will receive subcutaneous doses of placebo for 12 weeks.

Drug: Placebo for ABBV-295

Interventions

ABBV-295 DRUG

Subcutaneous Injections

ABBV-295 Part 1; ABBV-295 Part 2

Placebo for ABBV-295 DRUG

Subcutaneous Injections

Placebo for ABBV-295 Part 1; Placebo for ABBV-295 Part 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

CenExel ACT- Anaheim Clinical Trials /ID# 280879

Anaheim, California, 92801, United States

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)