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Weight Loss for Ulcerative Colitis in Obese Patients

This study is looking at whether a weight loss medication, phentermine-topiramate, can help obese patients with ulcerative colitis (UC) improve their condition. Researchers know that obesity can make UC worse, leading to more active disease and other problems. This study will compare phentermine-topiramate to a placebo (an inactive pill) over 22 weeks. You might be able to join if you are an adult between 18 and 80 years old, have a body mass index (BMI) of 30 or higher, and have an established diagnosis of active UC or are dependent on corticosteroids. The main goal is to see if participants lose at least 5% of their body weight by 22 weeks. The current status of this study is unclear.

Study design
This study is interventional and plans to enroll 40 participants. Participants will be randomly assigned to receive either phentermine-topiramate or a placebo.
What's involved
Participants will take an oral medication once daily for 22 weeks. They will also have clinic visits with an obesity medicine specialist for diet and lifestyle counseling.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring weight loss is at 22 weeks after starting the intervention.

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NCT04721873

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
University of California, San Diego
~40 participants
Updated 2023-05-16 on ClinicalTrials.gov
What's tested:Phentermine-TopiramatePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weight loss - 5%
Measured over 22 weeks

Conditions

Colitis, Ulcerative
Obesity

Explore related trials

ObesityUlcerative Colitis

Where it's being run

1 sites across 1 states
California1

Who to contact

Siddharth Singh, MD
[email protected]
8582462352
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Weight loss - 5%22 weeks

    Proportion of patients with ≥5% weight loss over baseline