Semaglutide Withdrawal for Weight Changes
(REST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best strategies for managing weight maintenance after using semaglutide, a medication that aids weight loss. Researchers aim to determine if gradually reducing the dosage of semaglutide results in better outcomes, such as maintaining weight loss and improving heart health, compared to abruptly stopping the medication. The study seeks participants who have used semaglutide, reduced their weight by at least 10%, and maintained a stable weight, but do not have heart disease or type 2 diabetes. Eligible participants should have a BMI of 30 or higher, or a BMI of 27 with weight-related health issues, such as sleep apnea or high blood pressure. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to significant research that could lead to new treatment options.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does require that you are not using any other weight-loss drugs. If you are on semaglutide, the study involves either gradually reducing or stopping it immediately.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that semaglutide is generally safe. Various studies have demonstrated significant weight loss in people taking semaglutide without major safety issues. For instance, one study found participants lost about 11.85% of their starting weight, and the treatment was well-tolerated. Another study confirmed that semaglutide aided weight loss and remained safe over a long period, with participants benefiting for four years.
While some side effects can occur, they are usually mild. Common ones include nausea and diarrhea, which often improve as the body adjusts to the medication. The FDA has approved semaglutide for weight management, indicating its safety has been thoroughly evaluated for this purpose. This trial examines different methods of discontinuing the medication, making it important to observe how the body reacts upon stopping. Overall, semaglutide has a strong safety record for aiding weight loss.12345Why are researchers excited about this trial's treatment?
Semaglutide is unique because it's a GLP-1 receptor agonist, initially used for diabetes, now showing promise for weight loss. Unlike traditional weight loss medications that often suppress appetite or increase metabolism, semaglutide mimics a hormone that regulates appetite and food intake. Researchers are excited because it targets the underlying biological pathways of hunger, potentially offering more sustainable weight management. Additionally, the trial explores different withdrawal strategies, which could lead to better long-term outcomes and understanding of how to maintain weight loss after stopping the medication.
What evidence suggests that this trial's treatments could be effective for weight maintenance?
Research has shown that semaglutide aids in weight loss. One study found that participants taking semaglutide lost an average of 14.9% of their body weight over 68 weeks, while those on a placebo lost only 2.4%. Another study reported that 84.1% of individuals using semaglutide experienced significant weight loss over a year. This medication mimics a hormone in the body that helps control appetite, leading to reduced food intake. Although semaglutide has proven effective for weight loss, this trial will compare two methods of discontinuation: gradual dose reduction and immediate cessation, to determine the best way to maintain weight loss after stopping the medication.13567
Are You a Good Fit for This Trial?
This trial is for individuals with obesity, possibly accompanied by hypertension. Participants should have been on semaglutide treatment and are now looking to discontinue it. The study will explore the effects of stopping semaglutide suddenly versus tapering off gradually.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either gradual dose reduction of semaglutide by 25% every 4 weeks or immediate cessation at week 16
Follow-up
Participants are monitored for changes in body weight, blood pressure, and hormones after treatment cessation
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
Trial Overview
The trial investigates two methods of discontinuing semaglutide: an abrupt stop and a gradual dose reduction. It aims to determine which method better maintains weight loss benefits and impacts heart risk profile and energy balance hormones.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will reduce semaglutide dosage by 25% every 4-weeks until complete treatment cessation at week 16
Participants will discontinue treatment at once at week 16
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor
Heart and Stroke Foundation of Canada
Collaborator
Citations
Real-World Weight Loss Observed With Semaglutide and ...
Most patients in both cohorts achieved clinically meaningful [9] weight loss over 1 year, with 84.1% in the semaglutide 2.4 mg cohort and 86.2% ...
Once-Weekly Semaglutide in Adults with Overweight or ...
Results. The mean change in body weight from baseline to week 68 was −14.9% in the semaglutide group as compared with −2.4% with placebo, for ...
Long-term weight loss effects of semaglutide in obesity ...
Individual changes in body weight with semaglutide and placebo were striking; still, 67.8% achieved 5% or more weight loss and 44.2% achieved 10 ...
Weight Loss Outcomes and Semaglutide Treatment for ...
In this cohort study of 175 patients with overweight or obesity, the total body weight loss percentages achieved were 5.9% at 3 months and 10.9% at 6 months.
A Systematic Review and Meta-Analysis of Randomized ...
Our results suggest that semaglutide is beneficial for promoting sustained weight loss in adults with overweight/obesity and without diabetes.
Efficacy and Safety of Semaglutide for Weight Loss in ...
Among individuals with obesity without type 2 diabetes, subcutaneous semaglutide is effective for weight loss with an 11.85% reduction from baseline compared ...
Real‐World Evidence on Weight Loss and Safety With ...
Semaglutide led to significant weight loss with a favorable safety profile in clinical trials; participants in the STEP 1 trial achieved an ...
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