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NCT04721873 · ClinicalTrials.gov registry record · Phase 2
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
A Phase 2 study of Obesity and Colitis, Ulcerative, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04721873 is a Phase 2 study of Obesity and Colitis, Ulcerative that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 40 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04721873, a Phase 2 study of Obesity and Colitis, Ulcerative, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Phentermine-Topiramate
Study Locations (1)
California
- University of California San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04721873
The ClinicalTrials.gov registry entry for NCT04721873 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04721873 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04721873 about?
NCT04721873 is a clinical study titled "Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients". 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 biol...
What is the current status of trial NCT04721873?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-12-18. Estimated completion is 2024-06-30.
What conditions does trial NCT04721873 study?
This clinical trial studies the following conditions: Obesity, Colitis, Ulcerative.
What interventions are being tested in trial NCT04721873?
The interventions under investigation include: Placebo (DRUG), Phentermine-Topiramate (DRUG).
Who is sponsoring clinical trial NCT04721873?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04721873 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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