Who is eligible for clinical trial NCT05975580?

Participants must meet protocol criteria for Obesity. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05975580 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-05

Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery (NCT05975580)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: University of California, Irvine

🩺 Plain-English Summary (8th-Grade Level)

This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (34 items).

Location: University of California Irvine Medical Center — Orange, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Male and female subjects aged 18-70 years
Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least 18 months ago
Weight regain of ≥5% relative to post-surgery nadir weight
Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with weight-related comorbidities
Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry
Must be able to provide written informed consent

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Type 1 diabetes
Insulin-dependent type 2 diabetes
Fasting plasma glucose (FPG) ≥240 mg/dL
Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥100 mm Hg on the average of three seated measurements after being at rest for at least 5 minutes
History of significant (as determined by the investigator) and unstable cardiovascular disease including coronary artery disease, arrhythmias, severe congestive heart failure, or stroke
Use of monoamine oxidase inhibitors, current or within 2 weeks
Hyperthyroidism or other significant thyroid disease
Angle-closure glaucoma
Agitated states
History of drug abuse within the past year
Known hypersensitivity or idiosyncrasy to sympathomimetic amines

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of California Irvine Medical Center — Orange, California

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗