Semaglutide for Weight Loss
(THRIVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how losing weight with semaglutide, a once-weekly medication, might affect brain health and structure in overweight adults. Researchers aim to determine if extra body fat links to brain changes and whether these changes improve with weight loss. Participants will undergo various assessments, including brain scans (MRIs), while using semaglutide. This trial suits individuals aged 35-55 who are overweight (BMI between 27 and 40) and willing to self-administer the medication and follow study procedures. As a Phase 4 trial, semaglutide is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.
What is the safety track record for semaglutide?
Research has shown that semaglutide is safe for weight management. In several studies, participants who took semaglutide once a week at a dose of 2.4 mg tolerated it well and lost significant weight without unexpected safety issues.
The safety profile of semaglutide resembles other drugs in its group, known as GLP-1 receptor agonists, typically causing similar side effects that are often mild and manageable.
One study found semaglutide effective across different groups of people, regardless of age, sex, or race, with no major safety concerns reported. Additionally, the FDA has already approved semaglutide for other conditions, indicating a well-understood safety record.
Overall, semaglutide is considered a safe option for weight loss, supported by multiple studies and its existing approval for other uses.12345Why are researchers enthusiastic about this study treatment?
Semaglutide is unique because it is a medication traditionally used for diabetes management but has shown promise in aiding weight loss by mimicking a hormone that targets areas of the brain regulating appetite and food intake. Unlike other weight loss treatments that may focus on appetite suppression or fat absorption, semaglutide works by enhancing the feeling of fullness, which helps reduce overall calorie intake. Researchers are excited about this treatment because it could offer a more effective and sustainable weight loss solution, especially for individuals who struggle with obesity or being overweight despite trying other weight loss methods.
What is the effectiveness track record for semaglutide in weight loss?
Research has shown that semaglutide aids in weight loss. In studies, adults taking semaglutide weekly lost about 13.2% to 14.9% of their body weight. Approximately 89% of those using semaglutide lost at least 5% of their weight, compared to only 38% who took a placebo (a harmless pill with no active ingredient). Notably, more than half of the users moved to a lower BMI category, indicating they became less overweight. In some cases, 12% of users even reached a healthy BMI level. These findings support semaglutide’s effectiveness in helping people lose a significant amount of weight and maintain it. Participants in this trial will be divided into two groups: the Overweight Group, who will receive semaglutide, and the Lean Group, who will not receive any intervention.12346
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 35-55 who have obesity. Participants should not have other major health problems and must be able to safely undergo MRI scans.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer semaglutide once a week for 80 weeks and complete various assessments including metabolic, cognitive, mood, dietary, and MRI scans
Follow-up
Participants are monitored for changes in brain health and other outcomes after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
Trial Overview
The study tests if weekly self-injections of semaglutide for about a year and a half can improve brain health in people with obesity, as seen on MRI scans. Participants also complete various health assessments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
semaglutide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alain Dagher
Lead Sponsor
Citations
Once-Weekly Semaglutide in Adults with Overweight or ...
2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight.
Clinical Insight on Semaglutide for Chronic Weight ... - PMC
The 13.2% initial weight loss of patients treated with semaglutide 2.4 mg in this trial was slightly lower than the 14.9% weight loss in STEP 1, though STEP 1 ...
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. Older anti- ...
4.
novomedlink.com
novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/chronic-weight-management.htmlChronic Weight Management Trial Results | Wegovy ...
Percentage of patients achieving ≥5% weight loss at 72 weeks: 88.7% of patients with Wegovy® HD vs 38.3% with placebo†. Treatment regimen estimand:.
Long-term weight loss effects of semaglutide in obesity ...
In the semaglutide group, 12.0% of patients achieved a BMI <25 kg m−2, which is considered the healthy BMI category, compared with 1.2% for ...
Semaglutide: 4-Year Weight Loss and Cardiovascular ...
There were no unexpected safety issues with semaglutide in the SELECT trial. ... For the other abstract on safety data, click here. For abstract ...
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