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Phentermine-Topiramate for Obesity

Phase 2
Recruiting
Led By Aaron Kelly, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
Be younger than 65 years old
Must not have
History of glaucoma
Any history of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 day of randomization, week 26 and week 52 visits.
Awards & highlights

Summary

This trial is testing a combination of two drugs, phentermine and topiramate, to see if it can help adolescents with severe obesity keep off lost weight.

Who is the study for?
Adolescents aged 12-17 with severe obesity (BMI ≥120% of the 95th percentile or BMI ≥35 kg/m2) can join this trial. They must not be using stimulants, have diabetes, major psychiatric disorders, uncontrolled hypertension, or a history of certain medical conditions like kidney stones. Sexually active females must use two forms of contraception.Check my eligibility
What is being tested?
The trial is testing if phentermine-topiramate can help maintain weight loss after meal replacement therapy in adolescents with severe obesity. It compares this drug combination to a placebo and measures its effects on appetite control and energy expenditure.See study design
What are the potential side effects?
Potential side effects include changes in heart rhythm or blood pressure, cognitive issues, bone health concerns, and possibly increased risk for kidney stones or other metabolic disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am severely obese according to BMI standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of glaucoma.
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I have a history of seizures.
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I have a heart defect or a serious irregular heartbeat.
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I have not had thoughts of suicide or self-harm in the last 30 days.
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I have diabetes (type 1 or 2).
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I have been diagnosed with obesity caused by a single gene.
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I have been diagnosed with an overactive thyroid.
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I have been treated with growth hormone in the past.
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I have used a monoamine oxidase inhibitor in the last 14 days.
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I have had kidney stones in the past.
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I am currently taking medication that stimulates my body.
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I have been diagnosed with unstable depression.
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I have had gallstones in the past.
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I have a thyroid condition that hasn't been treated.
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I have had weight loss surgery in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 day of randomization, week 26 and week 52 visits.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 day of randomization, week 26 and week 52 visits. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To measure changes in BMI.
To measure changes in C-reactive protein (CRP).
Body Weight Changes
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Meal Replacement TherapyExperimental Treatment1 Intervention
Participants who are enrolled in the study will be administered a short-term (six weeks) meal replacement induction period. Because the trial is deigned to evaluate weight loss maintenance, participants must achieve at least 5% BMI reduction at week six of the meal replacement period in order to be randomized. Subjects will be asked to strictly follow the eating regimen, which will include a total of approximately 1,000 kcals per day of commercially-available liquid shakes (breakfast and lunch), pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables. Shakes/meals will be provided free of charge - fruits/vegetables will be purchased by the participants. Guidance will be provided regarding the use of the meal replacement shakes at school, and participants will be encouraged to engage in family meal sessions despite eating different foods.
Group II: Phentermine/TopiramateActive Control2 Interventions
Participants who achieve at least 5% BMI reduction at week six of the meal replacement period will be randomized (1:1) to receive either phentermine/topiramate or placebo. Participants randomized to phentermine/topiramate will start treatment at 3.75 mg/23 mg orally once daily in the morning for 14 days, then increased to 7.5 mg/46 mg orally once daily in the morning for 14 days, then be increased to 11.25 mg/69 mg orally once daily in the morning for 14 days, then increased to 15 mg/92 mg orally once daily in the morning for the remainder of the trial. Following the final study visit, participants will be down-titrated gradually by taking medication every other day for seven days before stopping treatment altogether.
Group III: PlaceboPlacebo Group2 Interventions
Participants who achieve at least 5% BMI reduction at week six of the meal replacement period will be randomized (1:1) to receive either phentermine/topiramate or placebo. Participants randomized to the placebo will receive inert tablets that look like the active comparator. In order to mimic the active comparator arm, subjects randomized to the placebo arm will up titrate their placebo at the beginning of the study treatment and will down titrate as in the active comparator arm. Participants will be instructed to take the medication under the supervision of a parent/guardian and pill counts of returned product will serve as a proxy of treatment compliance.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,395 Previous Clinical Trials
1,553,182 Total Patients Enrolled
69 Trials studying Obesity
20,606 Patients Enrolled for Obesity
Aaron Kelly, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
246 Total Patients Enrolled
1 Trials studying Obesity
126 Patients Enrolled for Obesity

Media Library

Meal Replacement Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04298203 — Phase 2
Obesity Research Study Groups: Placebo, Meal Replacement Therapy, Phentermine/Topiramate
Obesity Clinical Trial 2023: Meal Replacement Therapy Highlights & Side Effects. Trial Name: NCT04298203 — Phase 2
Meal Replacement Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298203 — Phase 2
~34 spots leftby Jun 2025