A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-295 in Healthy Japanese Subjects With Overweight or Obesity
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events (AEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ABBV-295 Part 1
Participants will receive subcutaneous doses of ABBV-295 for 12 weeks.
Intervention: ABBV-295 (Drug)
Placebo for ABBV-295 Part 1
Participants will receive subcutaneous doses of placebo for 12 weeks.
Intervention: Placebo for ABBV-295 (Drug)
ABBV-295 Part 2
Participants will receive subcutaneous doses of ABBV-295 for 12 weeks.
Intervention: ABBV-295 (Drug)
Placebo for ABBV-295 Part 2
Participants will receive subcutaneous doses of placebo for 12 weeks.
Intervention: Placebo for ABBV-295 (Drug)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 138 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.
Secondary Outcomes
No secondary outcomes reported