Colitis, Ulcerative · Obesity
Phentermine-Topiramate for Weight Loss in Adults With Ulcerative Colitis
This 22-week study asks how phentermine-topiramate, compared with placebo, affects weight, safety, tolerability, ulcerative colitis outcomes, inflammation, and biologic drug levels in adults with obesity and active ulcerative colitis.
Registry title: Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- Phentermine-Topiramate or Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Siddharth Singh, MD8582462352sis040@ucsd.edu
- Sponsor
- University of California, San Diego
Research question
Compared with placebo, what are the effects of phentermine-topiramate on weight loss, safety, tolerability, ulcerative colitis outcomes, inflammatory burden, and biologic drug levels?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80.
- The study is looking for people with obesity, defined as a body mass index of at least 30 kg/m².
- The study is looking for people with an established ulcerative colitis diagnosis supported by clinical, endoscopic, and pathology evidence.
- The study is looking for people with active ulcerative colitis or corticosteroid dependence who are starting a biologic or flaring despite stable biologic treatment.
- The registry lists one recruiting location at the University of California San Diego in La Jolla, California.
Participation overview
What participation may involve
Participants take phentermine-topiramate or matching placebo once daily for 22 weeks, undergo dose increases during the first four weeks, and attend obesity-medicine clinic visits for intensive diet and lifestyle counseling. What participation may involve: - Take oral phentermine-topiramate or matching placebo once daily. - Follow a four-week dose-increase schedule, with slower increases or dose reduction if side effects occur. - Attend clinic visits with an obesity medicine specialist for intensive diet and lifestyle counseling. - Have weight, treatment discontinuation due to adverse events, ulcerative colitis remission, fecal calprotectin, and biologic drug levels assessed. The reported intervention period is 22 weeks. Clinic visits with an obesity medicine specialist are reported, but the registry does not state their number or timing.
Study interventions
What participants may receive or do
- Phentermine-Topiramate: Participants assigned to this group take oral phentermine-topiramate once daily for 22 weeks. The dose begins at 3.75-23 mg and is increased during the first four weeks toward 15-92 mg; slower increases or a lower maximum dose are allowed if side effects occur.
- Placebo: Participants assigned to this group take a matching placebo that is increased on the same schedule as the active study drug.
Study design
How the comparison works
This is an estimated 40-person phase 2 parallel-group study comparing phentermine-topiramate with matching placebo over 22 weeks. Participants are randomly assigned in a 1:1 ratio to phentermine-topiramate or placebo. The registry describes quadruple masking: participants, care providers, investigators, and outcome assessors are masked to treatment assignment. The control group receives a matching placebo that is titrated like the active intervention. The stated 1:1 assignment means each participant has an equal chance of receiving phentermine-topiramate or matching placebo.
Reported activities
Procedures and tests
- Body weight is measured to determine weight change and whether participants lose at least 5% or 10% from baseline.
- Treatment-related adverse events are monitored, including whether they lead to stopping study therapy.
- Ulcerative colitis symptoms and recent prednisone use are assessed for corticosteroid-free clinical remission using the two-item patient-reported outcome measure called PRO2.
- A stool measurement of fecal calprotectin is used to assess biochemical remission.
- Biologic trough concentration, meaning the drug level measured at its lowest point before a subsequent dose, is assessed.
- Screening may involve confirming ulcerative colitis through existing clinical, endoscopic, and pathology evidence.
- Screening may involve blood counts, liver enzymes, kidney function, blood pressure, fasting glucose or hemoglobin A1c, and fasting triglycerides because the eligibility criteria specify limits for these results.
- Depressive symptoms may be assessed with the nine-item Patient Health Questionnaire because a score of 10 or higher is an exclusion criterion.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 80 years old.
- Body mass index must be at least 30 kg/m².
- Ulcerative colitis must be established through clinical and endoscopic evidence supported by a pathology report.
- Participants must have active ulcerative colitis under the stated symptom-score rules or be unable to taper corticosteroids as specified.
- Participants must be starting a new listed biologic or flaring despite a stable maintenance dose of a biologic.
- Weight must have changed by less than 5 kg during the four weeks before screening and randomization.
- Participants must be able to speak or understand English and give written informed consent.
Possible reasons someone may not be able to join
- Pregnant or lactating women are excluded.
- Several serious gastrointestinal conditions, prior colectomy or diverting stoma, short bowel syndrome, active tuberculosis or other bacterial infection, and cancer are exclusion factors.
- An unstable or uncontrolled medical disorder may exclude someone if the investigator believes it could affect results or safety.
- Specified abnormalities in blood counts, liver enzymes, or kidney function are exclusion factors.
- Exclusions include blood pressure above 140/95 mmHg unless controlled with medication, specified glucose or triglyceride levels, type 1 diabetes, coronary artery disease, stroke, or symptomatic peripheral arterial disease.
- The specified kidney-stone history, hyperthyroidism, or a seizure disorder excludes participation.
- Specified depression, suicidal behavior or ideation, substantial current depressive symptoms, unstable antidepressant treatment, or bupropion treatment are exclusion factors.
- A history of glaucoma, increased eye pressure, or treatment for either condition excludes participation.
- Prior bariatric surgery, more than 5 kg of recent weight fluctuation, a very-low-calorie diet, or a formal weight-loss program within three months are exclusion factors.
- An eating disorder history, drug or alcohol abuse within the preceding year, or use of another sympathomimetic medication such as one for attention-deficit/hyperactivity disorder may exclude participation.
- A known allergy to the study medication excludes participation.
Important unknowns
What the record does not make clear
- The registry mentions clinic visits with an obesity medicine specialist but does not provide the number, timing, or length of visits.
- The registry requires biologic treatment but does not fully explain which ulcerative colitis medicines must continue unchanged during the study.
- The registry does not provide a complete list of medication washout requirements before enrollment.
- The registry does not state what rescue treatment is available if ulcerative colitis worsens during the study.
- Endoscopic evidence is required to establish the diagnosis, but the registry does not say whether a new endoscopy is performed for the study.
- The registry does not explain which study-related or usual-care costs are covered or billed to insurance.
- The registry does not state whether participants are compensated.
- The registry does not report reimbursement or support for transportation, parking, lodging, or meals.
- The registry does not say whether any visits or assessments can be completed remotely.
- The registry does not state whether phentermine-topiramate is available through the study after 22 weeks.
- The La Jolla location is labeled recruiting, but recruitment status was last verified in May 2023 and the estimated completion date was June 2024.
Before contacting the site
Questions for the study team
- Is the La Jolla site currently enrolling, and are all treatment groups still open?
- How many visits are required, when do they occur, and which must be in person?
- Which biologic and other ulcerative colitis treatments must remain stable, and what changes are allowed?
- What happens if my ulcerative colitis worsens during the study?
- Will screening or follow-up require a colonoscopy or sigmoidoscopy?
- What side effects are monitored, and what rules determine slower titration, dose reduction, or stopping treatment?
- Which study costs are covered, is compensation offered, and is travel or parking support available?
- What treatment or follow-up is available after the 22-week study period?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and how might starting or continuing a biologic during this study affect that stability?
- Would any of my current ulcerative colitis medicines need to change, and how could treatment continuity be protected?
- What approved weight-management and ulcerative colitis treatment alternatives should I understand before considering this study?
- Do my medical history, mental health history, blood pressure, laboratory results, or other medicines raise particular concerns about phentermine-topiramate?
- How should my gastroenterology team and the research team coordinate monitoring and respond if my ulcerative colitis worsens?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- University of California, San Diego
- Organization class
- Other
- Organization study ID
- 190419
- Lead sponsor
- University of California, San Diego
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Intervention
Interventions: Drug: Phentermine-Topiramate
Placebo Comparator
Placebo
Interventions: Drug: Placebo
Interventions
Drug
Phentermine-Topiramate
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 as follows 3.75-23mg x 1 week --\> 7.5-46mg x 1 week --\> 11.25-69mg x 1 week --\> 15-92mg. Patients who experience side effects would undergo slower titration, and dose would be down-titrated and capped at highest tolerated dose.
Drug
Placebo
Matching placebo, titrated as active intervention
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (7)
- adults aged 18-80yRegistry-derived · unreviewed
- BMI ≥30kg/m\^2Registry-derived · unreviewed
- established diagnosis of UC based on clinical and endoscopy evidence corroborated by histopathology reportRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- starting a new biologic agent (TNFα antagonists, vedolizumab, ustekinumab) or flaring despite stable maintenance dose of biologic agentRegistry-derived · unreviewed
- stable weight (\<5kg weight change) for preceding 4 weeks prior to screening and randomizationRegistry-derived · unreviewed
- able to speak or understand English and provide written informed consent.Registry-derived · unreviewed
Exclusion criteria (13)
- pregnant or lactating womenRegistry-derived · unreviewed
- prisonersRegistry-derived · unreviewed
- 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, cancerRegistry-derived · unreviewed
- 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 safetyRegistry-derived · unreviewed
- 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 normalRegistry-derived · unreviewed
- 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 diseaseRegistry-derived · unreviewed
- history of nephrolithiasis (H/O kidney stone \>1 time, and kidney stone within 1y prior to start of study), hyperthyroidism, seizure disorderRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- history of (or treatment for) glaucoma or increased intraocular pressureRegistry-derived · unreviewed
- 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 studyRegistry-derived · unreviewed
- smoking cessation within previous 3 months or plans to quit during the study periodRegistry-derived · unreviewed
- history of eating disorder or drug/alcohol abuse within the preceding 1 year concomitant use of other sympathomimetic medications, for example for ADHDRegistry-derived · unreviewed
- known allergy to study medicationRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Weight loss - 5%
Time frame: 22 weeks
Proportion of patients with ≥5% weight loss over baseline
Secondary outcome
Weight loss - 10%
Time frame: 22 weeks
Proportion of patients with ≥10% weight loss over baseline
Secondary outcome
Absolute weight loss
Time frame: 22 weeks
Absolute weight loss from baseline
Secondary outcome
Discontinuation
Time frame: 22 weeks
Discontinuation of therapy due to treatment-related adverse events
Secondary outcome
Corticosteroid-free clinical remission
Time frame: 22 weeks
PRO2 remission, with no prednisone use within 1 week of assessment
Secondary outcome
Biochemical remission
Time frame: 22 weeks
Fecal calprotectin (FC) ≤50μg/g
Recruiting locations in the United States
University of California San Diego
RecruitingLa Jolla, California, 92037, United States
Siddharth Singh858-246-2352sis040@ucsd.edu
Siddharth Singh, MD
Central study contacts
Registry dates
- First posted
- Jan 25, 2021
- Primary completion
- Jun 30, 2024
- Overall completion
- Jun 30, 2024
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.