Subcutaneous ABBV-295 injections in healthy Japanese adults 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
This trial will test the safety, tolerability, and how the body processes ABBV-295 given as subcutaneous injections in healthy Japanese adults with overweight or obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Anaheim, California) |
| Trial ID | NCT07514260 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial gives healthy adult Japanese participants with BMI 23.0–35.0 subcutaneous injections of ABBV-295 or matching placebo and monitors them for adverse events and tolerability. Blood samples will be collected over a defined schedule to characterize pharmacokinetics. Participants are screened for stable weight, normal glucose control, and prior use of obesity medications is exclusionary. The goal is to generate safety and PK data to inform dosing in later studies.
Who should consider this trial
Good fit: Healthy adult Japanese participants (first- or second-generation of full Japanese descent) with BMI rounded to 23.0–35.0 kg/m2 who have had no recent large weight change and do not have diabetes or use obesity medications.
Not a fit: People with diabetes-level glucose or HbA1c, recent ≥5% weight change, current or recent use of weight-loss medications, non-Japanese ancestry, or BMI outside 23.0–35.0 kg/m2 are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, the results could define safe dosing and tolerability for ABBV-295 in this population and support further development for overweight and obesity treatments.
How similar studies have performed: Early-phase PK and tolerability trials are standard and have supported later success for some obesity biologics, but ABBV-295 itself is a novel agent and has not been proven effective yet.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Anaheim, California
- CenExel ACT- Anaheim Clinical Trials /ID# 280879 — Anaheim, California, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.