Weight Loss Drug for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of California, San Diego

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Approximately 20-40% of patients with ulcerative colitis (UC) are obese. The investigators have demonstrated that obesity adversely impacts disease course in patients with UC, leading to higher risk of persistently active disease, surgery, hospitalization, and treatment failure, particularly in biologic-treated patients. Intentional weight loss is effective in improving disease outcomes in patients with inflammatory arthritis, but there is limited data on its impact in UC. While dietary interventions for weight loss have limited efficacy and endoscopic bariatric interventions may be too invasive in patients with UC with active gastrointestinal symptoms, pharmacological weight loss with a highly effective oral agent may be a novel strategy to induce weight loss and augment the efficacy of biologic therapy in UC. Hence, the investigators are conducting a pilot, phase 2A, 22-week, randomized, placebo-controlled clinical trial of phentermine-topiramate in obese patients with active UC starting on a new biologic agent (infliximab, adalimumab, golimumab, vedolizumab). The overall objective is to (1) evaluate the efficacy, safety and tolerability of phentermine-topiramate, and (2) to assess the impact of pharmacological weight loss on clinical outcomes, inflammatory burden and biologic trough concentration in patients with UC. The central hypothesis is that phentermine-topiramate will be safe, effective, and well tolerated in patients with UC, and weight loss would achieve higher rates of clinical and biochemical remission, and higher biologic trough concentration.

Research Team

Eligibility Criteria

This trial is for adults aged 18-80 with obesity and active ulcerative colitis who are starting or already on biologic therapy. Participants must have a stable weight, speak English, and not be pregnant or breastfeeding. Exclusions include those with certain medical conditions like uncontrolled blood pressure, recent heart disease, kidney stones, severe depression, glaucoma, or unstable other diseases.

Inclusion Criteria

I have active ulcerative colitis or need steroids to manage it.

My weight has been stable, with less than a 5kg change, for the last 4 weeks.

I am between 18 and 80 years old.

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Exclusion Criteria

I have been treated for or have a history of glaucoma.

Prisoners

Known allergy to study medication

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Treatment Details

Interventions

Phentermine-Topiramate (Other)
Placebo (Other)

Trial OverviewThe study tests the safety and effectiveness of phentermine-topiramate as a weight loss aid alongside biologic treatments for ulcerative colitis in obese patients. It's a phase 2A trial comparing this medication to placebo over 22 weeks to see if it improves disease outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention