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Weight Loss Drug for Ulcerative Colitis

Phase 2
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active UC (Mayo Clinic score [MCS], 6-12; or active disease based on rectal bleeding score [RBS]=2 or 3 and stool frequency score=2 or 3) or dependent on corticosteroids (unable to taper below 10mg prednisone equivalent, or flaring within 2 months of stopping prednisone)
Adults aged 18-80 years
Must not have
History of (or treatment for) glaucoma or increased intraocular pressure
Prior bariatric surgery; >5 kg weight fluctuation in preceding 4 weeks, use of very-low-calorie diet, or participation in a formal weight loss program in the 3 months prior to the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 weeks

Summary

This trial is testing whether a weight loss drug is safe and effective in people with ulcerative colitis.

Who is the study for?
This trial is for adults aged 18-80 with obesity and active ulcerative colitis who are starting or already on biologic therapy. Participants must have a stable weight, speak English, and not be pregnant or breastfeeding. Exclusions include those with certain medical conditions like uncontrolled blood pressure, recent heart disease, kidney stones, severe depression, glaucoma, or unstable other diseases.
What is being tested?
The study tests the safety and effectiveness of phentermine-topiramate as a weight loss aid alongside biologic treatments for ulcerative colitis in obese patients. It's a phase 2A trial comparing this medication to placebo over 22 weeks to see if it improves disease outcomes.
What are the potential side effects?
Potential side effects of phentermine-topiramate may include increased heart rate and blood pressure, dry mouth, sleep disturbances, anxiety or mood changes. Serious risks could involve vision problems due to increased eye pressure or worsening of metabolic parameters.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have active ulcerative colitis or need steroids to manage it.
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I am between 18 and 80 years old.
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My ulcerative colitis diagnosis was confirmed by a doctor using tests and a biopsy.
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I am starting or already on a stable dose of a specific immune-targeting drug but my condition is getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated for or have a history of glaucoma.
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I haven't had major weight changes or followed strict diets recently.
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I have high blood pressure, high blood sugar, high triglycerides, type 1 diabetes, or heart/stroke issues.
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I have never had severe colon issues, major gut surgery, TB, or cancer.
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I have quit smoking in the last 3 months or plan to quit during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight loss - 5%
Secondary study objectives
Absolute weight loss
Biochemical remission
Corticosteroid-free clinical remission
+2 more

Side effects data

From 2022 Phase 3 trial • 193 Patients • NCT03374956
25%
During study
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Control Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phentermine-Topiramate
2017
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,178 Previous Clinical Trials
1,574,946 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
3,261 Patients Enrolled for Ulcerative Colitis

Media Library

Phentermine-Topiramate Clinical Trial Eligibility Overview. Trial Name: NCT04721873 — Phase 2
Ulcerative Colitis Research Study Groups: Intervention, Placebo
Ulcerative Colitis Clinical Trial 2023: Phentermine-Topiramate Highlights & Side Effects. Trial Name: NCT04721873 — Phase 2
Phentermine-Topiramate 2023 Treatment Timeline for Medical Study. Trial Name: NCT04721873 — Phase 2
~8 spots leftby Nov 2025
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