Phentermine‑topiramate to help obese adults with active ulcerative colitis
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial
This trial will test whether the weight‑loss medicine phentermine‑topiramate helps obese adults with active ulcerative colitis lose weight and improve their response to biologic treatment over 22 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | vedolizumab, ustekinumab, prednisone, infliximab, adalimumab, golimumab |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04721873 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with BMI ≥30 kg/m2, an established diagnosis of active ulcerative colitis (Mayo score 6–12 or specified rectal bleeding/stool frequency criteria), stable recent weight, and starting or failing biologic therapy are ideal candidates.
Not a fit: Patients who are not obese, are pregnant or lactating, or who have prior colectomy, intestinal strictures, toxic megacolon, or other excluded GI complications are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding phentermine‑topiramate could help obese patients with UC lose weight and improve their response to biologic therapy, potentially reducing flares, hospitalizations, and need for surgery.
How similar studies have performed: Weight loss has improved outcomes in inflammatory arthritis and phentermine‑topiramate reliably produces weight loss, but using pharmacologic weight loss specifically to boost biologic response in ulcerative colitis is largely untested and therefore novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
La Jolla, California
- University of California San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Study coordinator: Siddharth Singh, MD
- Email: sis040@ucsd.edu
- Phone: 8582462352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.