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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 22 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight loss - 5%
Secondary outcome measures
Absolute weight loss
Biochemical remission
Corticosteroid-free clinical remission
+2 moreSide effects data
From 2022 Phase 3 trial • 193 Patients • NCT0337495625%
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
1,121 Previous Clinical Trials
1,520,884 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
261 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for or have a history of glaucoma.I have had more than one kidney stone, a thyroid problem, or seizures.I haven't had major weight changes or followed strict diets recently.I have major depression but haven't had stable antidepressant treatment for the last 3 months.I have high blood pressure, high blood sugar, high triglycerides, type 1 diabetes, or heart/stroke issues.I have not had an eating disorder or abused substances in the last year and I'm not taking ADHD medication.I do not have any uncontrolled health issues that could affect the study or my safety.I have active ulcerative colitis or need steroids to manage it.My weight has been stable, with less than a 5kg change, for the last 4 weeks.I am between 18 and 80 years old.I have never had severe colon issues, major gut surgery, TB, or cancer.I have quit smoking in the last 3 months or plan to quit during the study.My ulcerative colitis diagnosis was confirmed by a doctor using tests and a biopsy.I am starting or already on a stable dose of a specific immune-targeting drug but my condition is getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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