ABBV-295 subcutaneous injections for adults 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
This trial will test whether ABBV-295 injections are safe, how they affect body weight, and how the drug is processed in adults with obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT07291232 on ClinicalTrials.gov |
What this trial studies
This is a phase 1, randomized interventional study comparing ABBV-295 subcutaneous injections with matching placebo in adults who have a body mass index of 30.0–45.0 kg/m2. The study measures adverse events, changes in body weight, and the pharmacokinetics of ABBV-295 after dosing. Key entry rules exclude people with recent weight change, uncontrolled diabetes, pregnancy, or recent use of obesity medications. Participants will attend screening and treatment visits at a clinical site in Grayslake, Illinois.
Who should consider this trial
Good fit: Adults with a BMI between 30.0 and 45.0 kg/m2 who are not pregnant or breastfeeding, have stable comorbidities, and have not had recent weight change or recent obesity drug use are appropriate candidates.
Not a fit: People with recent significant weight change, uncontrolled diabetes (HbA1c ≥ 6.5%), recent use of obesity medications, or who are pregnant or breastfeeding are unlikely to qualify or benefit from this phase 1 trial.
Why it matters
Potential benefit: If successful, ABBV-295 could become a new medication option that helps adults with obesity lose weight while being well tolerated.
How similar studies have performed: Phase 1 programs for new obesity drugs have sometimes shown early safety and weight effects, but ABBV-295 itself has limited published human results to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 278624 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.