NCT05975580 Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
| NCT ID | NCT05975580 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Irvine |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-08-29 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2023-08-29 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects aged 18-70 years 2. Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least 18 months ago 3. Weight regain of ≥5% relative to post-surgery nadir weight 4. Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with weight-related comorbidities 5. 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 6. Must be able to provide written informed consent Exclusion Criteria: 1. Type 1 diabetes 2. Insulin-dependent type 2 diabetes 3. Fasting plasma glucose (FPG) ≥240 mg/dL 4. 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 5. History of significant (as determined by the investigator) and unstable cardiovascular disease including coronary artery disease, arrhythmias, severe congestive heart failure, or stroke 6. Use of monoamine oxidase inhibitors, current or within 2 weeks 7. Hyperthyroidism or other significant thyroid disease 8. Angle-closure glaucoma 9. Agitated states 10. History of drug abuse within the past year 11. Known hypersensitivity or idiosyncrasy to sympathomimetic amines 12. Severe hepatic disease (non-alcoholic fatty liver disease or non-alcoholic steatohepatitis without portal hypertension or cirrhosis is acceptable) 13. End-stage renal disease 14. History of nephrolithiasis 15. Serum triglycerides ≥500 mg/dL 16. Cancer, not in remission, within the past 2 years except for adequately treated basal cell, squamous cell skin cancer, or in-situ cervical cancer 17. History of psychosis or bipolar disorder 18. Suicidal ideation or unstable/untreated major depressive disorder within the past year 19. Use of antidepressant medication that has not been at stable dose for at least 3 months 20. Hospital Anxiety and Depression Scale (HADS) score of ≥11 for depression or anxiety items 21. Binge Eating Scale (BES) score of ≥27 22. Alcohol use disorder within the past year 23. Epilepsy 24. Currently taking phentermine or topiramate or the combination, or products containing these drugs 25. Currently taking stimulants (e.g., Attention Deficit Hyperactivity Disorder medications) 26. Current use of prescription or over-the-counter weight loss drugs or supplements 27. Taking prescription or over-the-counter drugs or products, which in the opinion of the PI, could be associated with significant effects on body weight 28. Planning additional bariatric surgery procedures in the next 13 months 29. History of revisional bariatric surgery (revisional surgery after adjustable gastric banding is acceptable) 30. Currently participating in another weight loss program or have plans to participate in the next 13 months 31. Smoking cessation within the previous 3 months or plans to quit smoking in the next 13 months 32. Pregnant or breastfeeding or planning pregnancy in the coming 13 months 33. History of, or any existing condition that, in the opinion of the Principal Investigator, would interfere with the study outcomes or place the subject at unacceptable risk by participating in the study
Contact & Investigator
Kishore M Gadde, MD
PRINCIPAL INVESTIGATOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT05975580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05975580 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05975580 currently recruiting?
Yes, NCT05975580 is actively recruiting participants. Contact the research team at rahae@hs.uci.edu for enrollment information.
Where is the NCT05975580 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT05975580 clinical trial?
NCT05975580 is sponsored by University of California, Irvine. The principal investigator is Kishore M Gadde, MD at University of California, Irvine. The trial plans to enroll 120 participants.
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