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RecruitingPhase 1

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

Lead sponsor

AbbVie

Asset

ABBV-295

Subcutaneous · Amylin analog

Listed sites

1

Recruiting sites

1

Enrollment

24

estimated

Study population

Key I/E criterion

BMI 23-35

Primary endpoint

Adverse Events (AEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07514260
Org study IDM26-009

Timeline

Milestones

Study start2026-03-31actual
Study first posted2026-04-07actual
Last update posted2026-04-15actual
Primary completion2027-01estimated (month precision)
Study completion2027-01estimated (month precision)

Assets

Investigational agents

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participants with Adverse Events (AEs)

Time frame:Up to approximately 138 days

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.