Under construction – not a live service
Sign in
Taking people in United StatesPhase 2

Tests a weight loss pill alongside biologic treatment in obese people with ulcerative colitis

Tests a weight loss pill with a placebo in obese adults with ulcerative colitis.

Key facts

Who runs it
University of California, San Diego
Where
La Jolla, United StatesSee the site
Trial code
Registry title
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
Status
Recruiting
Phase
Phase 2
People taking part
40 people, planned
Started
18 Dec 2020
Planned end
30 Jun 2024
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Phentermine-Topiramate
  • Placebo
Record updated
16 May 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active ulcerative colitis and obesity who are starting a new biologic medicine or having a flare despite a stable biologic dose.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Ulcerative colitis confirmed by clinical and endoscopy findings and a pathology report. The disease must be active (Mayo Clinic score 6-12, or rectal bleeding score 2 or 3 with stool frequency score 2 or 3) or depend on corticosteroids.
Earlier treatment
Must be starting a new biologic agent (TNFα antagonist, vedolizumab, ustekinumab) or flaring despite a stable maintenance dose of a biologic. Weight must be stable (less than 5kg (11 lb (5 kg)) change) for the 4 weeks before screening and randomization. No bariatric surgery. No very-low-calorie diet or formal weight loss program in the 3 months before the study.
Biomarker or test result
BMI of 30kg/m² or more.

Main reasons for not taking part

  • Pregnant or breastfeeding women, and prisoners
  • History of toxic megacolon, colectomy, diverting stoma, short bowel syndrome, active tuberculosis or other bacterial infection, or cancer
  • Uncontrolled heart, lung, liver, kidney or other serious medical conditions, or significant abnormal lab results
  • History of kidney stones, hyperthyroidism, seizure disorder, glaucoma, eating disorder, or recurrent major depression
  • Allergy to the study medication

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • 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
  • history of (or treatment for) glaucoma or increased intraocular pressure
  • known allergy to study medication
  • 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
  • pregnant or lactating women
  • prisoners

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United States

  • University of California San DiegoLa Jolla, United StatesContact: Siddharth SinghTaking people

About the trial

What the trial wants to find out

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 patients with inflammatory arthritis, but there is limited data on its impact in UC. While dietary interventions for weight loss have limited efficacy and endoscopic bariatric interventions may be too invasive in patients with UC with active gastrointestinal symptoms, pharmacological weight loss with a highly effective oral agent may be a novel strategy to induce weight loss and augment the efficacy of biologic therapy in UC.

Read full original descriptionShow less

Hence, the investigators are conducting a pilot, phase 2A, 22-week, randomized, placebo-controlled clinical trial of phentermine-topiramate in obese patients with active UC starting on a new biologic agent (infliximab, adalimumab, golimumab, vedolizumab).

The overall objective is to (1) evaluate the efficacy, safety and tolerability of phentermine-topiramate, and (2) to assess the impact of pharmacological weight loss on clinical outcomes, inflammatory burden and biologic trough concentration in patients with UC. The central hypothesis is that phentermine-topiramate will be safe, effective, and well tolerated in patients with UC, and weight loss would achieve higher rates of clinical and biochemical remission, and higher biologic trough concentration.

The 2 groups in the trial

  • InterventionTreatment being tested

    Treatment: Phentermine-Topiramate

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial
Plain-language title
Tests a weight loss pill alongside biologic treatment in obese people with ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04721873, who can take part
Record updated
16 May 2023