RecruitingPhase 1NCT07291232

A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Subcutaneous Doses of ABBV-295 in Adult Subjects With Obesity

Sponsor

AbbVie

Enrollment

96 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria3

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.

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