Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT04721873

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

Led by University of California, San Diego · Updated on 2023-05-16

40

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-80 years
  • Body mass index (BMI) of 30 kg/m2 or higher
  • Established diagnosis of ulcerative colitis confirmed by clinical and endoscopy evidence supported by histopathology
  • Active ulcerative colitis with Mayo Clinic score 6-12 or active disease based on rectal bleeding score of 2 or 3 and stool frequency score of 2 or 3, or corticosteroid dependent
  • Starting a new biologic agent or experiencing flare despite stable biologic maintenance dose
  • Stable weight with less than 5 kg change in the 4 weeks prior to screening and randomization
  • Able to speak or understand English and provide written informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Prisoners
  • History or current toxic megacolon, abdominal abscess, symptomatic intestinal or colonic stricture, colectomy, diverting stoma, short bowel syndrome, active tuberculosis, other bacterial infections, or cancer
  • Unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorders that could affect study results or patient safety
  • Significant laboratory abnormalities including severe anemia, leukopenia, thrombocytopenia, thrombocytosis, elevated liver enzymes, or high creatinine
  • Blood pressure over 140/95 mmHg unless controlled by medication
  • Fasting blood glucose over 240 mg/dl, HbA1c over 9%, fasting triglycerides over 400 mg/dl
  • Type 1 diabetes, coronary artery disease, stroke, or symptomatic peripheral arterial disease
  • History of kidney stones, hyperthyroidism, or seizure disorder
  • Major depression with suicidal behavior or intent, recent use of unstable antidepressants
  • History or treatment of glaucoma or increased eye pressure
  • Prior bariatric surgery or recent significant weight fluctuation or weight loss programs
  • Smoking cessation within 3 months or plans to quit during study
  • History of eating disorder or drug/alcohol abuse in past year
  • Use of other stimulant medications or known allergy to study drugs

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of California San Diego

La Jolla, California, United States, 92037

Actively Recruiting

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Research Team

S

Siddharth Singh, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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