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NOT YET RECRUITING
NCT07832084
PHASE4

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

Sponsor: Jing Luo

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-11-01

Completion Date

2028-09-30

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

GLP-1 dose reduction

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

DRUG

non-GLP weight loss medication

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

DRUG

Maintenance of GLP-1 dose

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

BEHAVIORAL

Resistance exercise regimen

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.

BEHAVIORAL

Lifestyle/nutrition counseling

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).

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States