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

Phase 4Not Yet RecruitingNCT07832084

Jing Luo60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

GLP-1 dose reductionDRUG

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

non-GLP weight loss medicationDRUG

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

Maintenance of GLP-1 doseDRUG

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

Resistance exercise regimenBEHAVIORAL

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 counselingBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Participant Inclusion Criteria: * Aged18 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 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.

Outcomes

Primary Outcomes

Feasibility of recruitment and retention

The primary study endpoint is feasibility. This trial will be considered feasible if the study achieves: * ≥60% consent to approach rate. * ≥80% enrolled to consent rate. * A total of at least 60 participants (20 per study arm). * ≥80% protocol completion rate among enrolled participants at 6 months. * ≥70% protocol completion rate among enrolled participants at 12 months.

Time frame: Completion of participation, up to 12 months.

Secondary Outcomes

Acceptability of lower-dose, alternate frequency dosing or switching to non-incretin based weight loss therapy

Acceptability of the individual comparators will be based on participant responses to a survey questionnaire developed for this study. The proposed comparators will be considered acceptable if at the 6-month study visit: * ≥70% of patients would recomend the intervention to other patients using incretin based therapies for weight loss, OR * ≥70% of patients agree or strongly agree that the randomly assigned intervention has "helped me maintain me weight loss or level of function".

Time frame: 6-month study visit