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Recruiting NCT07514260

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

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABBV-295, Placebo for ABBV-295.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug ABBV-295
    Subcutaneous Injections
  • Drug Placebo for ABBV-295
    Subcutaneous Injections

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 138 days]

Eligibility criteria

Inclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • CenExel ACT- Anaheim Clinical Trials /ID# 280879 — Anaheim

Identifiers

NCT: NCT07514260 · M26-009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗