Phentermine-Topiramate + Lifestyle Intervention for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have any of the listed conditions like diabetes, hypertension, or heart disease, you would not be eligible to participate.
What safety data exists for Phentermine-Topiramate treatment for obesity?
Phentermine-Topiramate (Qsymia) has been approved for obesity treatment in adults since 2012 and in pediatric patients aged 12 and older since 2022. Safety concerns include teratogenicity, increased heart rate, psychiatric and cognitive effects, and metabolic acidosis. Clinical trials have shown it to be effective for weight loss with a favorable adverse effect profile compared to monotherapy. However, longer-term cardiovascular safety data is still needed.12345
Is the drug Phentermine-Topiramate a promising treatment for obesity?
Yes, Phentermine-Topiramate is a promising treatment for obesity. It helps reduce weight by decreasing appetite and increasing the feeling of fullness. Studies show it leads to significant weight loss when combined with diet and lifestyle changes. It has been approved for use in both adults and adolescents in the US.12367
What data supports the idea that the drug Phentermine-Topiramate + Lifestyle Intervention for Obesity is an effective treatment?
The available research shows that Phentermine-Topiramate, when combined with lifestyle changes like a reduced-calorie diet and increased physical activity, leads to significant weight loss. In clinical trials, more than 50% of participants lost at least 10% of their starting weight and maintained this loss for up to two years. This combination drug is more effective than using either phentermine or topiramate alone. Additionally, it has been shown to improve health-related quality of life and reduce risk factors for heart disease. Compared to other treatments, this drug offers a promising option for long-term weight management.12489
Who Is on the Research Team?
Lisa L Morselli, MD PhD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are enrolled in a weight loss program based on lifestyle changes, including a 6-month subscription to a calorie-reduced meal replacement program with lifestyle coaching
Follow-up
Participants are monitored for changes in metabolic rate and hormone levels after weight loss
What Are the Treatments Tested in This Trial?
Interventions
- Lifestyle Intervention with Meal Replacement Program
- Phentermine-Topiramate
Lifestyle Intervention with Meal Replacement Program is already approved in United States, European Union, Canada for the following indications:
- Weight Loss
- Obesity Management
- Metabolic Syndrome
- Weight Loss
- Obesity Management
- Type 2 Diabetes Management
- Weight Loss
- Obesity Management
- Metabolic Syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor