UCRecruiting
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
Phase 2 · Testing Phentermine-Topiramate · 1 site · University of California, San Diego
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Phentermine-Topiramate (a drug) as a possible treatment. Condition(s) listed: Colitis, Ulcerative and Obesity.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- adults aged 18-80y
- BMI ≥30kg/m^2
- established diagnosis of UC based on clinical and endoscopy evidence corroborated by histopathology report
Plus 4 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2020-12-18.
- Main results expected around 2024-06-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Weight loss - 5% (22 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative; Obesity |
| Lead sponsor | University of California, San Diego |
| Enrollment | 40 (estimated) |
| Start date | 2020-12-18 |
| Primary completion (est.) | 2024-06-30 |
| First posted | 2021-01-25 |
| Last updated | 2023-05-16 |
| Official title | Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial |
| ClinicalTrials.gov ID | NCT04721873 |
Interventions
- Phentermine-Topiramate (Drug)
Patients will be randomized to either once-daily, oral phentermine-topiramate 15-92mg or placebo, in a 1:1 fashion, for 22 weeks, with clinic visits with an obesity medicine specialist, for intensive counseling for diet and lifestyle intervention. All patients will be dose-titrated within the first 4 weeks, starting at phentermine-topiramate 3.75-23mg, or placebo. Dose titration will be performed … - Placebo (Drug)
Matching placebo, titrated as active intervention
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Diego | La Jolla, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.