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Obesity & OverweightWeight managementWeight lossPeptides and GLP-1Exercise and fitnessNutrition and dietBehavioralDrugBehavioralPhase 4

What this study is

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 phentermine \& topiramate. 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 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, and bicep curls two to three times a week. If these exercises are deemed too easy, participants may choose to do regular pushups, planks, lunges and/or add a resistance band.

What's being tested

  • GLP-1 dose reduction

    Intervention · DRUG

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

  • non-GLP weight loss medication

    Intervention · DRUG

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

  • Maintenance of GLP-1 dose

    Intervention · DRUG

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

  • Resistance exercise regimen

    Intervention · 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

    Intervention · 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).

Study details

Official title
OFF-RAMP Feasibility: a Pilot Trial Comparing Different Off-ramping Strategies for Maintaining Weight Loss Among Adults Using Incretin Based Therapies for Obesity
Sponsor
Jing Luo
Conditions
Obesity & Overweight · Cardiometabolic Health Indicators
Enrolling
60 people
Starts
2026-12
Est. completion
2028-09-30
Design
Open-label, randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗