GLP-1 Regimens for Obesity

(OFF-RAMP Trial)

JL
Overseen ByJing Luo, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Jing Luo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JL

Jing Luo, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with obesity or overweight, possibly with metabolic syndrome, who are interested in maintaining weight loss. Participants must be able to attend study visits and follow a home exercise program. Specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Able to provide informed consent
Pre-treatment diagnosis of obesity (BMI≥30kg/m2)
I am taking a high dose of semaglutide or tirzepatide.
See 3 more

Exclusion Criteria

Pregnancy, nursing, or seeking to become pregnant in the next year
History of substance use disorder
History of suicidal ideation
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • Bupropion and Naltrexone
  • GLP-1 agonists
  • Lifestyle/Nutrition Counseling
  • Resistance Exercise Regimen

Trial Overview

The study compares three approaches: staying on full-dose GLP-1 medication, reducing the GLP-1 dose, or switching to non-GLP weight loss drugs (bupropion & naltrexone). All groups get lifestyle counseling and do resistance exercises at home. Participants are randomly assigned to one group.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Non-incretin based therapyExperimental Treatment3 Interventions
Group II: Low dose, alternate frequencyExperimental Treatment3 Interventions
Group III: Usual careActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jing Luo

Lead Sponsor

Trials
1
Recruited
400+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+