Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s

What this study is testing ClinicalTrials.gov NCT07832084 ↗

Description as written by the study sponsor.

The purpose of this research is to compare weight loss among 3 groups: 1. people who stay on a GLP-1 drug at full strength (Group 1) 2. people who have their dose tapered to every other week, meaning slowly decreasing the dose and frequency of the full prescription you are currently taking (Group 2) 3. people who go off their GLP-1 and instead take an alternative weight loss drug or combination of drugs called bupropion \& naltrexone. These are not GLP-1 medications. (Group 3) The investigators want to see if the second and third options are effective at weight loss maintenance. This study will include a total of 60 participants. Participants will be randomly assigned to one of the three study groups. The goals of this current study are to: 1. determine the acceptability of these proposed treatment strategies, 2. collect data about how people's weight changes early on and throughout the study and how well people tolerate the medications. 3. determine whether it is feasible to recruit for a larger, follow-up study. There are 3 on site visits: at the start, and then 6 and 12 months. The study team will do monthly phone calls in between those visits. At the visits on site visits the study team will do various physical measures and collect blood for lab testing and provide participants with counseling to help with weight loss. The study team will instruct participants in a home-based resistance exercise regimen to help maintain muscle mass. This will include exercises such as: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, bicep curls two to three times a week. If these exercises are deemed too easy, participants may choose to do regular push ups, planks, lunges and/or add a resistance band.

Treatments tested

• GLP-1 dose reduction Drug

  Participants in this intervention arm will receive a reduced GLP-1 dose compared to usual care.

• non-GLP weight loss medication Drug

  Participants in this intervention arm will be switched to a non-GLP weight loss medication.

• Maintenance of GLP-1 dose Drug

  Participants in this arm will maintain their high-potency GLP-1 dosage.

• Resistance exercise regimen Behavioral

  All participants will be recommended to do a "low touch" home-based resistance exercise regimen. These strength exercises will include: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, bicep curls two to three times a week. If too easy for a particular subject, the study may recommend regular push ups, planks, lunges and/or add a resistance band.

• Lifestyle/nutrition counseling Behavioral

  Participants will be provided with guideline concordant weight loss maintenance education and counseling (i.e., calorie restriction, amount and intensity of physical activity, self-monitoring of weight, and measuring portion sizes).