Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
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.