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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

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 0, 4, 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Energy intake

Other study objectives

Binge eating

Grazing

Loss-of-control eating

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

Topiramate

2013

Completed Phase 4

~3400

Phentermine

2014