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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jan 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a weight loss medication called phentermine-topiramate in obese patients who have ulcerative colitis (UC) and are starting a new biologic treatment. The goal is to see if this medication can help these patients lose weight safely and effectively, which may improve their UC symptoms and enhance the effectiveness of their biologic therapy. The trial will last for 22 weeks and will involve participants taking either the weight loss medication or a placebo (a non-active pill) to compare results.

To be eligible, participants need to be adults aged 18-80 with a body mass index (BMI) of 30 or higher and an active diagnosis of UC. They should also be starting a new biologic treatment or experiencing disease flare-ups despite stable treatment. Participants will need to have maintained a stable weight for the four weeks before the trial starts. It’s important to know that there are some health conditions that could exclude someone from participating, such as certain serious medical disorders or medications that might interfere with the study. Those who join can expect regular check-ins and support throughout the trial to monitor their safety and health.

Gender

ALL

Eligibility 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