Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 18, 2020

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2024

Conditions
Colitis, UlcerativeObesity
Interventions
DRUG

Phentermine-Topiramate

Patients will be randomized to either once-daily, oral phentermine-topiramate 15-92mg or placebo, in a 1:1 fashion, for 22 weeks, with clinic visits with an obesity medicine specialist, for intensive counseling for diet and lifestyle intervention. All patients will be dose-titrated within the first 4 weeks, starting at phentermine-topiramate 3.75-23mg, or placebo. Dose titration will be performed as follows 3.75-23mg x 1 week --\> 7.5-46mg x 1 week --\> 11.25-69mg x 1 week --\> 15-92mg. Patients who experience side effects would undergo slower titration, and dose would be down-titrated and capped at highest tolerated dose.

DRUG

Placebo

Matching placebo, titrated as active intervention

Trial Locations (1)

92037

RECRUITING

University of California San Diego, La Jolla

All Listed Sponsors
lead

University of California, San Diego

OTHER