OFF-RAMP Feasibility: a Pilot Trial Comparing Different Off-ramping Strategies for Maintaining Weight Loss Among Adults Using Incretin Based Therapies for Obesity
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment and retention
研究概览
简要总结
The purpose of this research is to compare weight loss among 3 groups:
- people who stay on a GLP-1 drug at full strength (Group 1)
- 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)
- 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:
- determine the acceptability of these proposed treatment strategies,
- collect data about how people's weight changes early on and throughout the study and how well people tolerate the medications.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Usual care
Maintenance of high-potency GLP-1 based therapy. Participants will continue their dose at enrollment for the entire duration of study follow-up. This is the current standard of care when the medication is covered and available.
干预措施: Maintenance of GLP-1 dose (Drug)
Usual care
Maintenance of high-potency GLP-1 based therapy. Participants will continue their dose at enrollment for the entire duration of study follow-up. This is the current standard of care when the medication is covered and available.
干预措施: Resistance exercise regimen (Behavioral)
Usual care
Maintenance of high-potency GLP-1 based therapy. Participants will continue their dose at enrollment for the entire duration of study follow-up. This is the current standard of care when the medication is covered and available.
干预措施: Lifestyle/nutrition counseling (Behavioral)
Low dose, alternate frequency
GLP-1 dose reduction to lower-dose, alternate frequency. Participants on semaglutide at enrollment will gradually reduce their dose from 2.4mg to 1.7mg to 1.0mg to 0.5mg once a week to 0.5mg every other week. Participants on tirzepatide at baseline will gradually reduce their dose from 15mg to 12.5mg to 10mg to 7.5mg to 5mg once a week to 5mg every other week. Dose reductions are scheduled every 4 weeks.
干预措施: GLP-1 dose reduction (Drug)
Low dose, alternate frequency
GLP-1 dose reduction to lower-dose, alternate frequency. Participants on semaglutide at enrollment will gradually reduce their dose from 2.4mg to 1.7mg to 1.0mg to 0.5mg once a week to 0.5mg every other week. Participants on tirzepatide at baseline will gradually reduce their dose from 15mg to 12.5mg to 10mg to 7.5mg to 5mg once a week to 5mg every other week. Dose reductions are scheduled every 4 weeks.
干预措施: Resistance exercise regimen (Behavioral)
Low dose, alternate frequency
GLP-1 dose reduction to lower-dose, alternate frequency. Participants on semaglutide at enrollment will gradually reduce their dose from 2.4mg to 1.7mg to 1.0mg to 0.5mg once a week to 0.5mg every other week. Participants on tirzepatide at baseline will gradually reduce their dose from 15mg to 12.5mg to 10mg to 7.5mg to 5mg once a week to 5mg every other week. Dose reductions are scheduled every 4 weeks.
干预措施: Lifestyle/nutrition counseling (Behavioral)
Non-incretin based therapy
After gradually reducing GLP-1 therapy, participants will start bupropion with naltrexone. Participants will gradually reduce their semaglutide or tirzepatide dosage following the schedule of the "low dose, alternate frequency" arm until either semaglutide is 0.5mg once a week or tirzepatide is 5mg once a week. Participants will then start bupropion at 75mg twice a day (maintenance dose 150mg twice a day). Dosage for naltrexone would start at 25mg once a day, with an increase to 25mg twice per day if there is a favorable benefit/risk profile.
干预措施: non-GLP weight loss medication (Drug)
Non-incretin based therapy
After gradually reducing GLP-1 therapy, participants will start bupropion with naltrexone. Participants will gradually reduce their semaglutide or tirzepatide dosage following the schedule of the "low dose, alternate frequency" arm until either semaglutide is 0.5mg once a week or tirzepatide is 5mg once a week. Participants will then start bupropion at 75mg twice a day (maintenance dose 150mg twice a day). Dosage for naltrexone would start at 25mg once a day, with an increase to 25mg twice per day if there is a favorable benefit/risk profile.
干预措施: Resistance exercise regimen (Behavioral)
Non-incretin based therapy
After gradually reducing GLP-1 therapy, participants will start bupropion with naltrexone. Participants will gradually reduce their semaglutide or tirzepatide dosage following the schedule of the "low dose, alternate frequency" arm until either semaglutide is 0.5mg once a week or tirzepatide is 5mg once a week. Participants will then start bupropion at 75mg twice a day (maintenance dose 150mg twice a day). Dosage for naltrexone would start at 25mg once a day, with an increase to 25mg twice per day if there is a favorable benefit/risk profile.
干预措施: Lifestyle/nutrition counseling (Behavioral)
结局指标
主要结局
Feasibility of recruitment and retention
时间窗: Completion of participation, up to 12 months.
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.
次要结局
- Acceptability of lower-dose, alternate frequency dosing or switching to non-incretin based weight loss therapy(6-month study visit)
研究者
Jing Luo
Associate Professor
University of Pittsburgh