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

OFF-RAMP Feasibility: a Pilot Trial Comparing Different Off-ramping Strategies for Maintaining Weight Loss Among Adults Using Incretin Based Therapies for Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study team will do monthly phone calls in between those visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests three ways to keep weight off: stay on a full-dose GLP-1 weight loss drug, slowly lower the dose and take it every other week, or switch to phentermine and topiramate, which are not GLP-1 drugs. It is for adults who had obesity before treatment and are at or near their goal weight. The 60 people in the study will be placed in one of three groups by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You can understand the study and agree to take part.
  • You had obesity before treatment, with a BMI of 30 or higher. BMI is a measure based on height and weight.
  • You take semaglutide at a dose of at least 1.7 mg or tirzepatide at a dose of at least 10 mg.
  • You are at or near a goal weight set by you or your doctor. This should usually be at least 5% below your weight before starting a GLP-1 drug.
  • You have taken an incretin-based weight loss drug, such as a GLP-1 drug, for at least 6 months.

Who can't join

  • You have type 2 diabetes or existing heart or blood vessel disease. Certain heart rhythm problems, high pressure in lung arteries, serious heart valve disease, heart artery disease, stroke, heart failure, or uncontrolled high blood pressure also rule you out.
  • You are pregnant, breastfeeding, or planning to become pregnant in the next year.
  • You have had weight loss surgery.
  • You are not willing to lower your GLP-1 dose or switch to a non-GLP-1 weight loss drug.
  • You cannot take bupropion/naltrexone because of long-term opioid use, seizures, other medicines containing bupropion, uncontrolled high blood pressure, or use of MAO inhibitors, a type of medicine.
  • You have an overactive thyroid, or have or are at risk for glaucoma, an eye disease that can harm sight.
  • You have a history of substance use disorder or thoughts of suicide.
  • You use lithium or metformin, or have used an MAO inhibitor within 14 days.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Participant Inclusion Criteria: * Aged 18 years or older. * Able to provide informed consent. * Pre-treatment diagnosis of obesity (BMI≥30kg/m2). * On a high potency GLP-1 based therapy (defined as semaglutide ≥1.7 mg or tirzepatide≥10mg). * Has achieved, or are close to achieving, a "target body weight." Target body weight will be defined by each individual patient through self-report or their treating clinician but should generally be at least 5% below their weight prior to first starting GLP-1 based therapy. * Has been on an incretin-based weight loss therapy for at least 6 months. Participant Exclusion Criteria: * Diagnosis of type 2 diabetes or pre-existing cardiovascular disease. * Pregnancy or nursing or are seeking to become pregnant in the next year. * Have had bariatric surgery. * Unwilling to reduce the dose of their GLP-1 medication for weight loss, or who are unwilling to switch to another non-GLP-1based weight loss medication. * Contraindications to phentermine: pre-existing cardiac arrhythmias, primary pulmonary hypertension, serious cardiac valvular disease, CAD, CVA, CHF, uncontrolled hypertension. * Contraindications to bupropion/naltrexone: chronic opioid use, seizure disorders, use of other bupropion containing products, uncontrolled hypertension, monoamine oxidase inhibitors. * Hyperthyroidism. * Glaucoma, or at risk for glaucoma. * History of substance use disorder. * History of suicidal ideation. * Concomitant monoamine oxidase inhibitors within 14 days. * Use of lithium. * Use of metformin.

Study sites (1)

PA