Phentermine-Topiramate for Obese Patients with Ulcerative Colitis

Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients

Recruiting Phase 2 Interventional Study
Colitis, Ulcerative Obesity
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of California, San Diego · Other
Who this trial is looking for

This trial is looking for adults with ulcerative colitis who are also obese. Participants will take a medication called phentermine-topiramate for 22 weeks to see if it helps with weight loss and improves their condition.

Are You a Good Fit for This Trial?
Rules you out History of kidney stonesType 1 diabetesCoronary artery diseaseSeizure disorderHistory of eating disorderDrug abuse

You may be able to join if

  • I am between 18 and 80 years old.
  • I have a body mass index (BMI) of 30 or more.
  • I have been diagnosed with ulcerative colitis.
  • I have active ulcerative colitis or am dependent on corticosteroids.
  • I am starting a new biologic treatment for ulcerative colitis.
  • My weight has not changed by more than 5 kg in the last 4 weeks.
  • I can understand English and give informed consent.

You may not be able to join if

  • I am pregnant or breastfeeding.
  • I am currently in prison.
  • I have a current or past history of serious bowel issues or cancer.
  • I have uncontrolled health problems that may affect my safety.
  • I have significant blood pressure or blood sugar issues.
  • I have had kidney stones in the past year.
  • I have a history of major depression or suicidal thoughts.
  • I have had eye problems like glaucoma.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 patient…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * adults aged 18-80y * BMI ≥30kg/m\^2 * established diagnosis of UC based on clinical and endoscopy evidence corroborated by histopathology report * active UC (Mayo Clinic score \[MCS\], 6-12; or active disease based on rectal bleeding score \[RBS\]=2 or 3 and stool frequency sc…
Contacts

Siddharth Singh, MD

8582462352

sis040@ucsd.edu

CONTACT