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Pharmacotherapy + Lifestyle Counseling for Obesity Management (PROJECT-BARI Trial)

Phase 4
Recruiting
Led By Kishore M Gadde, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 0, 4, 12
Awards & highlights

PROJECT-BARI Trial Summary

This trial tests if medicine and lifestyle changes can help people keep weight off after weight loss surgery.

Who is the study for?
Adults aged 18-70 who had bariatric surgery (SG or RYGB) between 1.5 and 10 years ago, with a BMI ≥30 kg/m2 (or ≥27 kg/m2 with weight-related issues), experiencing weight regain of at least 5%. Must not have conditions like epilepsy, uncontrolled hypertension, severe heart disease, type 1 diabetes or insulin-dependent type 2 diabetes, certain mental health disorders, recent drug abuse history, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial is testing if Phentermine and Topiramate medications combined with lifestyle counseling can help reverse weight gain after bariatric surgery compared to a placebo. Participants are randomly assigned to different treatments in stages based on their initial response.See study design
What are the potential side effects?
Phentermine may cause increased blood pressure and heart rate, insomnia, nervousness; Topiramate might lead to tingling sensations in limbs, dizziness, taste changes. Both drugs could potentially affect mood and cognitive functions.

PROJECT-BARI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 0, 4, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 0, 4, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent weight loss at Month 12 - Phentermine vs placebo
Percent weight loss at Month 12 - Phentermine/Topiramate
Percent weight loss at Month 12 - Topiramate vs placebo
Secondary outcome measures
Energy intake
Other outcome measures
Binge eating
Grazing
Loss-of-control eating

PROJECT-BARI Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Group F: Phentermine 7.5 mg/Topiramate 50 mgExperimental Treatment2 Interventions
Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 15 mg or phentermine/topiramate 7.5/50 mg during Months 5-12. For Group F, topiramate will be dosed at 25 mg daily for the 15 days in Month 5 and 50 mg daily thereafter,
Group II: Group E: Phentermine 15 mgExperimental Treatment1 Intervention
Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 15 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.
Group III: Group D: Phentermine 7.5 mgExperimental Treatment1 Intervention
Phentermine will be started at 7.5 mg daily. Responders at Month 4 will continue the same treatment until Month 12.
Group IV: Group C: Phentermine 7.5 mg/Topiramate 50 mgExperimental Treatment2 Interventions
Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.
Group V: Group B: Topiramate 100 mgExperimental Treatment1 Intervention
Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.
Group VI: Group A: Topiramate 50 mgExperimental Treatment1 Intervention
Topiramate will be started at 25 mg daily and the dose will be increased to 50 mg daily after 15 days. Responders at Month 4 will continue the same treatment until Month 12.
Group VII: Group P: PlaceboPlacebo Group1 Intervention
Placebo group will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phentermine
2017
Completed Phase 4
~1360
Topiramate
2013
Completed Phase 4
~3400

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,922,923 Total Patients Enrolled
10 Trials studying Obesity
21,717 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,472 Total Patients Enrolled
446 Trials studying Obesity
588,818 Patients Enrolled for Obesity
Kishore M Gadde, MDPrincipal InvestigatorUniversity of California, Irvine
1 Previous Clinical Trials
225 Total Patients Enrolled
1 Trials studying Obesity
225 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the opportunity to join this medical experiment?

"To qualify for this experiment, individuals must be between 18 and 70 years of age with a diagnosis of obesity. Approximately 120 people are needed to complete the study."

Answered by AI

Is it prudent to administer Topiramate 50 mg to individuals in Group A?

"Our research team has rated the safety of Group A: Topiramate 50 mg as a 3, justified by its Phase 4 status which confirms it is an approved medical intervention."

Answered by AI

Does the age limit for this trial extend beyond 18 years of age?

"In accordance with the stipulated requirements, potential participants must be aged at least 18 years old and no more than 70 years old."

Answered by AI

Can individuals still join this research endeavor?

"Per the information featured on clinicaltrials.gov, this medical study is not actively recruiting participants. It was first posted to the website on August 10th 2023 and has since been edited as recently as August 1st 2023; however, there are an abundance of other studies that are currently enrolling volunteers."

Answered by AI

Who else is applying?

What site did they apply to?
University of California Irvine Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
Kishore M Gadde, MD 2023. "Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05975580.
~80 spots leftby Apr 2027
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