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Phentermine-Topiramate + Lifestyle Intervention for Obesity

N/A
Recruiting
Led By Lisa L Morselli, MD PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
diabetes (type 2 or type 1)
active cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Summary

This trial looks for biomarkers that could help predict how someone will respond to weight loss, in terms of their metabolism.

Who is the study for?
This trial is for individuals with a BMI of 30 or higher, from any ethnic background. It's not suitable for those with heart disease, active cancer, post-transplant patients, weight over 400 lbs., HIV/AIDS, pregnant or breastfeeding women, smokers, and people with liver or kidney disease, diabetes (type 1 or type 2), or hypertension.Check my eligibility
What is being tested?
The study tests if phentermine-topiramate combined with lifestyle changes affects metabolic adaptation after weight loss differently than just lifestyle changes and meal replacements. Researchers are looking at how the body adjusts its energy use during and after dieting.See study design
What are the potential side effects?
Phentermine-topiramate can cause dry mouth, constipation, numbness in limbs; it may also affect mood and sleep. Lifestyle interventions might lead to temporary fatigue or hunger.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes.
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My cancer is currently active.
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I have had a solid organ or bone marrow transplant.
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I am living with HIV/AIDS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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
change in measured and predicted resting metabolic rate during and after weight loss
Secondary outcome measures
change in 24h urine catecholamines during and after weight loss
change in circulating AgRP during and after weight loss
change in circulating GLP-1 during and after weight loss
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: lifestyle intervention plus phentermine-topiramateExperimental Treatment1 Intervention
Participants will be enrolled in a weight loss program based on lifestyle changes and the use of phentermine-topiramate to aid with weight loss
Group II: lifestyle interventionExperimental Treatment1 Intervention
Participants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
614 Previous Clinical Trials
1,162,819 Total Patients Enrolled
3 Trials studying Weight Loss
280 Patients Enrolled for Weight Loss
Lisa L Morselli, MD PhDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Lifestyle Intervention with Meal Replacement Program (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05139420 — N/A
Weight Loss Research Study Groups: lifestyle intervention plus phentermine-topiramate, lifestyle intervention
Weight Loss Clinical Trial 2023: Lifestyle Intervention with Meal Replacement Program Highlights & Side Effects. Trial Name: NCT05139420 — N/A
Lifestyle Intervention with Meal Replacement Program (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139420 — N/A
Weight Loss Patient Testimony for trial: Trial Name: NCT05139420 — N/A
~17 spots leftby May 2025
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