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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 day of randomization, week 26 and week 52 visits.
Awards & highlights
Study 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 belowSelect...
I am severely obese according to BMI standards.
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.
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 moreTrial 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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,632 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of glaucoma.You currently smoke or use tobacco products.You are allergic to drugs that have similar effects to adrenaline.I have a history of seizures.I have a heart defect or a serious irregular heartbeat.You have a history of bulimia nervosa, a condition where you frequently eat large amounts of food and then try to get rid of it.Your depression score on the PHQ-9 questionnaire is higher than 15.I have not had thoughts of suicide or self-harm in the last 30 days.I have diabetes (type 1 or 2).I have been diagnosed with obesity caused by a single gene.I have been diagnosed with an overactive thyroid.You have tried to harm yourself on purpose in the past.I have been treated with growth hormone in the past.I have used a monoamine oxidase inhibitor in the last 14 days.I have had kidney stones in the past.I am between 12 and 17 years old, in puberty stage 2 or higher, and agree to use two forms of birth control if sexually active.I am currently taking medication that stimulates my body.I have been diagnosed with unstable depression.I have had gallstones in the past.I have used weight loss medication in the last 6 months.I am severely obese according to BMI standards.I have a thyroid condition that hasn't been treated.I have had weight loss surgery in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Meal Replacement Therapy
- Group 3: Phentermine/Topiramate
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are young adults eligible for this kind of research?
"According to the inclusion criteria, this trial is for patients aged 12-18. Out of the 893 total clinical trials, 216 are for minors and 677 are for elderly patients."
Answered by AI
Are there any health risks associated with Meal Replacement Therapy?
"While Phase 2 trials are not as reliable in terms of patient safety data, Meal Replacement Therapy showed some signs of being safe in clinical trials and was given a score of 2."
Answered by AI
How many total participants are in this research?
"That is correct. If you visit clinicaltrials.gov, you will see that this trial has an open call for participants. The listing was created on August 4th 2021 and the most recent update occurred on October 8th 2022. They are looking to enroll 143 people at a single site."
Answered by AI
Are there any available appointments for this research project?
"That is correct, the listing on clinicaltrials.gov says that this study is open for recruitment. This particular trial was first advertised on August 4th, 2021 and was last updated October 28th, 2022. They are looking to enroll 143 patients at a single site."
Answered by AI
What are people using Meal Replacement Therapy to improve?
"Meal Replacement Therapy is a common treatment for tonic-clonic seizures. It can also help patients experiencing lipidemia, lennox gastaut syndrome (lGS), and type 2 diabetes mellitus."
Answered by AI
Does this research build on other scientific investigations of Meal Replacement Therapy?
"There are currently 20 clinical trials underway that focus on studying Meal Replacement Therapy. 3 of those active trials are in their third and final Phase. The majority of these trials for Meal Replacement Therapy originated in Sherbrooke, Quebec; however, there are a total of 36 locations running studies related to this treatment option."
Answered by AI
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