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Anti-obesity drug

Medication arm for Obesity

Phase 2

Waitlist Available

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing if a medication combo can help teens at risk of obesity lose weight.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate effects of preventive pharmacotherapy and lifestyle-based weight gain prevention on body mass index between the medication arm and the placebo arm

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Medication armExperimental Treatment1 Intervention

Individuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment at 3.75 mg/23 mg orally once in the morning for 14 days, which will then be increased to 7.5 mg/46 mg orally once daily in the morning for the remainder of the trial. Participants who are unable to tolerate the dosing regimen will be maintained at the maximally tolerated dose. To further safeguard the risk/benefit balance we will utilize a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants will be reduced to the lowest-dose level (3.75 mg/23 mg) for 12 weeks. If the BMI remains below 20 kg/m2 at the lowest dose after 12 weeks, active treatment will be fully withdrawn. Participants at the end of the study will be down-titrated gradually with instructions to take the medication every other day for 7 days before stopping treatment altogether.

Group II: Placebo armPlacebo Group1 Intervention

Individuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment with a placebo (to keep the blind) and be asked to up-titrate the placebo dose after the first 14 days and then maintain the placebo dose for the remainder of the study. Individuals who are unable to tolerate the dosing regimen will have a down-titration protocol (to maintain the blind) as described in the medication arm. Likewise, we will employ a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants would be reduced to the lowest dose level of placebo for 12 weeks. If the BMI remains below 20 kg/m2 after 12 weeks, placebo treatment will be fully withdrawn. Individuals in the placebo arm will also have a placebo-based down-titration with instructions to take the placebo every other day for 7 days before stopping treatment altogether, to maintain the blind.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,378 Previous Clinical Trials

1,588,509 Total Patients Enrolled

69 Trials studying Obesity

20,749 Patients Enrolled for Obesity

Media Library

Phentermine/Topiramate (Anti-obesity drug) Clinical Trial Eligibility Overview. Trial Name: NCT05834062 — Phase 2

Obesity Research Study Groups: Medication arm, Placebo arm

Obesity Clinical Trial 2023: Phentermine/Topiramate Highlights & Side Effects. Trial Name: NCT05834062 — Phase 2

Phentermine/Topiramate (Anti-obesity drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05834062 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admittance to this trial restricted by age, and if so, what is the upper limit?

"For this medical trial, only individuals aged between 16 and 22 are eligible to participate."

Answered by AI

Could I potentially participate in this scientific investigation?

"This clinical trial seeks 140 participants with obesity and aged between 16 to 22. To be accepted, one must meet these criteria."

Answered by AI

What risks and hazards arise from using this particular medication?

"As there is only some evidence of safety and no clinical data showing efficacy, Medication Arm was given a relatively low rating of 2."

Answered by AI

Are participants currently being sought for this experiment?

"As indicated on clinicaltrials.gov, this medical investigation is not currently admitting patients. First published in September of 2023 and last amended in April of the same year, it has ceased recruiting; nonetheless, 1037 other trials are actively looking for participants presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity

2023. "Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05834062.