ABBV-295 for weight management in adults with obesity or overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 randomized, double-blind, placebo-controlled trial evaluating multiple doses of ABBV-295 versus placebo over 32 weeks. Adults with BMI 27–<30 with weight-related health issues or BMI ≥30 are eligible, and about 360 participants will be enrolled across ~70 sites in the U.S. and Puerto Rico. Participants receive subcutaneous injections of ABBV-295 or placebo, with assignment hidden from participants and investigators. The trial measures changes in body weight at Week 32 to determine safety and efficacy of the long-acting amylin analog for chronic weight management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* BMI ≥ 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) OR
* BMI ≥ 27.0 to \< 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD).

Exclusion Criteria:

* Self-reported change in body weight ≥ 5% within 3 months prior to Screening
* Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
* Fasting glucose ≥126 mg/dL (7.0 mmol/L) or random glucose test ≥ 200 mg/dL (11.1 mmol/L)
* History of type 1 or type 2 diabetes mellitus
* Treatment with any medication or product used for obesity or weight management within 180 days prior to Screening Unstable or severe cardiovascular disease (e.g., myocardial infarction, stroke, hospitalization for: unstable angina pectoris, transient ischemic attack, or heart failure) within 180 days prior to Screening.
* The participant has a concurrent disease, condition, or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

Where it's running

• Cahaba Research - Pelham /ID# 282381
  Pelham, Alabama, United States Recruiting
• Headlands Research - Scottsdale /ID# 282571
  Scottsdale, Arizona, United States Recruiting
• Arizona Clinical Trials /ID# 282372
  Tucson, Arizona, United States Recruiting
• John Muir Health - Concord /ID# 282469
  Concord, California, United States Recruiting
• Aurora FDRC Inc. /ID# 282494
  Costa Mesa, California, United States Recruiting
• NorCal Medical Research /ID# 283117
  Greenbrae, California, United States Recruiting

+14 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

  This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.

  Recruiting at 9 sites Phase 1 Amgen · Phoenix, Arizona and 8 other locations · NCT07908316

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Monthly dose of PF-08653944 vs placebo in Chinese adults who are overweight or obese

  This study tests whether berobenatide (PF-08653944) given once a month helps adults in China lose weight compared with a placebo.

  Recruiting Phase 3 Pfizer · Hefei, Anhui and 5 other locations · NCT07874633

• FutureShape Family: a family-based weight-management program with semaglutide for children and parents

  This trial tests whether a family-centered program that combines a prescription medication (semaglutide) with lifestyle support and app-based coaching can help adults with obesity and their children who are overweight/obese.

  Recruiting Phase 4 University of Copenhagen · Copenhagen · NCT07872904

• Home self-administration of a weight-management medicine with an autoinjector in adults who are overweight or obese

  This study tests whether adults who are overweight or have obesity can successfully self-administer maridebart cafraglutide at home using an autoinjector.

  Recruiting at 25 sites Phase 3 Amgen · San Diego, California and 24 other locations · NCT07871409

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.