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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

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

Primary study objectives

change in measured and predicted resting metabolic rate during and after weight loss

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met