NCT04721873

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

Recruiting now Phase 2 Last updated 16 May 2023

What this trial tests

Phase 2 trial testing Phentermine-Topiramate in Colitis, Ulcerative in 40 participants. Currently enrolling.

Timeline

18 December 2020

Primary endpoint
30 June 2024

30 June 2024

Quick facts

Lead sponsor	University of California, San Diego
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	18 December 2020
Primary completion	30 June 2024
Estimated completion	30 June 2024
Sites	1 location across United States

Drugs / interventions tested

• Phentermine-Topiramate — full drug profile →
• Placebo

Conditions studied

• Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
• Obesity — all drugs for Obesity →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 80, any sex, with Colitis, Ulcerative or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obesity and novel management of inflammatory bowel disease.
   Kim JH, Oh CM, Yoo JH. · · 2023 · cited 44× · PMID 37032724 · DOI 10.3748/wjg.v29.i12.1779
2. Impact of Obesity on Response to Biologic Therapies in Patients with Inflammatory Bowel Diseases.
   Bassi M, Singh S. · · 2022 · cited 32× · PMID 35320515 · DOI 10.1007/s40259-022-00522-0