NCT07291232PHASE1Recruiting
A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity
AbbVie
Start Date
11/19/2025
Completion Date
10/1/2026
Summary
This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.
Eligibility Criteria
Age Range: 18 years to 65 years
Inclusion Criteria:
* BMI ≥ 30.0 to ≤ 45.0 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) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
* A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.
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 or has been enrolled in an obesity trial within 180 days prior to study treatment administration.
Interventions
DRUG
ABBV-295
DRUG
Placebo
Conditions
Obesity
Locations
CenExel ACT- Anaheim Clinical Trials /ID# 283200
Anaheim, California 92801
United States
Acpru /Id# 278624
Grayslake, Illinois 60030
United States