Phentermine‑topiramate to help obese adults with active ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot, phase 2A, 22‑week randomized, placebo‑controlled trial comparing phentermine‑topiramate to placebo in obese adults with active ulcerative colitis who are starting or are on biologic therapy. Eligible participants are adults (18–80 years) with BMI ≥30 kg/m2 and active disease by Mayo Clinic score or specific rectal bleeding and stool frequency criteria. The trial pairs pharmacologic weight loss with standard biologic treatment to see if intentional weight reduction augments biologic effectiveness and clinical outcomes. Outcomes will focus on disease activity, weight change, and treatment response over the study period.

Why it matters

Who can join: the full rules

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 score=2 or 3) or dependent on corticosteroids (unable to taper below 10mg prednisone equivalent, or flaring within 2 months of stopping prednisone)
* starting a new biologic agent (TNFα antagonists, vedolizumab, ustekinumab) or flaring despite stable maintenance dose of biologic agent
* stable weight (\<5kg weight change) for preceding 4 weeks prior to screening and randomization
* able to speak or understand English and provide written informed consent.

Exclusion Criteria:

* pregnant or lactating women
* prisoners
* current or history of toxic megacolon, abdominal abscess, symptomatic intestinal or colonic stricture, history of colectomy or diverting stoma, short bowel syndrome, active tuberculosis or other bacterial infections, cancer
* any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety
* clinically meaningful laboratory abnormalities, including significant anemia (Hb\<8g/dl), leukopenia (\<3x10\^9/L), thrombocytopenia (\<100K) or thrombocytosis (\>600K), ALT/AST \>3x upper limit of normal, creatinine \>2x upper limit of normal
* blood pressure \>140/95mmHg (ok to include if BP controlled on anti-hypertensives), fasting blood glucose \>240mg/dl or HbA1c \>9%, fasting triglycerides \>400mg/dl at randomization, type 1 diabetes, coronary artery disease, stroke, or other symptomatic peripheral arterial disease
* history of nephrolithiasis (H/O kidney stone \>1 time, and kidney stone within 1y prior to start of study), hyperthyroidism, seizure disorder
* recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, current substantial depressive symptoms (patient health questionnaire-9, ≥10), use of antidepressant medication that has not been stable for the prior 3 months (bupropion-treated patients will be excluded)
* 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
* smoking cessation within previous 3 months or plans to quit during the study period
* history of eating disorder or drug/alcohol abuse within the preceding 1 year concomitant use of other sympathomimetic medications, for example for ADHD
* known allergy to study medication

Where it's running

• University of California San Diego
  La Jolla, California, United States Recruiting

Study contacts

• Study coordinator: Siddharth Singh, MD
• Email: sis040@ucsd.edu
• Phone: 8582462352

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.