Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
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|ClinicalTrials.gov Identifier: NCT04721873|
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : January 27, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative Obesity||Drug: Phentermine-Topiramate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
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.
|Placebo Comparator: Placebo||
Matching placebo, titrated as active intervention
- Weight loss - 5% [ Time Frame: 22 weeks ]Proportion of patients with ≥5% weight loss over baseline
- Weight loss - 10% [ Time Frame: 22 weeks ]Proportion of patients with ≥10% weight loss over baseline
- Absolute weight loss [ Time Frame: 22 weeks ]Absolute weight loss from baseline
- Discontinuation [ Time Frame: 22 weeks ]Discontinuation of therapy due to treatment-related adverse events
- Corticosteroid-free clinical remission [ Time Frame: 22 weeks ]PRO2 remission, with no prednisone use within 1 week of assessment
- Biochemical remission [ Time Frame: 22 weeks ]Fecal calprotectin (FC) ≤50μg/g
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721873
|Contact: Siddharth Singh, MDfirstname.lastname@example.org|