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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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 day of randomization, week 26 and week 52 visits.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To measure changes in BMI.

To measure changes in C-reactive protein (CRP).

Body Weight Changes

+6 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

0 / 16Eligibility criteria met