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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
CenExel Act- Anaheim Clinical Trials /ID# 283200
RECRUITING
Anaheim
Illinois
Acpru /Id# 278624
RECRUITING
Grayslake
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2027-03
Participants
Target number of participants: 80
Treatments
Experimental: ABBV-295 or Placebo-Group 1
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Experimental: ABBV-295 or Placebo-Group 2
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Experimental: ABBV-295 or Placebo-Group 3
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Experimental: ABBV-295 or Placebo-Group 3 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Experimental: ABBV-295 or Placebo-Group 4
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Experimental: ABBV-295 or Placebo-Group 4 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Experimental: ABBV-295 or Placebo-Group 5
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Experimental: ABBV-295 or Placebo-Group 6
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Related Therapeutic Areas
Sponsors
Leads: AbbVie