135 Participants Needed

Semaglutide for Obesity

Recruiting at 1 trial location
MS
Overseen ByMegan Schaefer
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using anti-obesity medications or certain diabetes medications (GLP1R agonists).

What data supports the effectiveness of the drug Semaglutide for obesity?

Research shows that Semaglutide, a drug approved for weight management, can help people lose about 15% of their initial weight over 68 weeks. It also improves heart health and physical functioning, making it a strong option for managing obesity.12345

Is semaglutide safe for humans?

Semaglutide has been studied for safety in people with obesity, and the main side effects reported are related to the stomach and intestines, like nausea and diarrhea. These side effects are generally consistent across different studies.56789

How is the drug Semaglutide unique for treating obesity?

Semaglutide is unique for treating obesity because it is a glucagon-like peptide-1 receptor agonist that can be administered once a week and has shown the largest weight loss of any obesity medication, with about 15% reduction in initial weight over 68 weeks, along with improvements in cardiovascular risk factors.24101112

What is the purpose of this trial?

This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.

Research Team

AA

Andres Acosta, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with obesity (BMI ≥30 kg/m2), possibly with controlled chronic conditions like hypertension. It's not for those who've had significant weight changes recently, are pregnant or planning to be, have a history of bariatric surgery, untreated severe psychiatric issues, substance or eating disorders, suicidal behavior, alcohol abuse problems, or are using anti-obesity drugs.

Inclusion Criteria

I am obese but my chronic conditions, if any, are under control.

Exclusion Criteria

Weight changes greater than 3% in the previous 3 months
A person who is pregnant or wanting to become pregnant
I have had weight loss surgery in the past.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo weekly for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Semaglutide
Trial Overview The study tests if saliva biomarkers can predict how well someone with obesity will respond to Semaglutide—a medication used for weight loss. Participants will either receive Semaglutide or a placebo without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide GroupExperimental Treatment1 Intervention
Subjects will take semaglutide weekly for 24 weeks
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will take placebo weekly for 24 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Phenomix Sciences

Collaborator

Trials
1
Recruited
140+

Findings from Research

Subcutaneous semaglutide is effective for weight loss in individuals with obesity without diabetes, resulting in an average weight reduction of 11.85% compared to placebo, based on a review of 4 randomized controlled trials involving 3,613 participants.
However, the treatment is associated with a higher risk of gastrointestinal adverse events, with patients being 1.59 times more likely to experience these issues, and a 2.19 times higher likelihood of discontinuing treatment due to adverse effects.
Efficacy and Safety of Semaglutide for Weight Loss in Obesity Without Diabetes: A Systematic Review and Meta-Analysis.Tan, HC., Dampil, OA., Marquez, MM.[2023]
Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.
In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.
Semaglutide for the treatment of obesity.Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]
Semaglutide 2.4 mg has been shown to be effective for weight loss in overweight and obese individuals, including those with type 2 diabetes, outperforming all pharmacological comparators in a systematic review of 41 randomized controlled trials.
Participants taking semaglutide were more likely to lose at least 5% of their baseline body weight after 12 weeks of treatment compared to those on other weight management medications, indicating its strong efficacy in promoting significant weight loss.
Semaglutide 2.4 Mg for the Management of Overweight and Obesity: Systematic Literature Review and Meta-Analysis.Smith, I., Hardy, E., Mitchell, S., et al.[2022]

References

Efficacy and Safety of Semaglutide for Weight Loss in Obesity Without Diabetes: A Systematic Review and Meta-Analysis. [2023]
Semaglutide for the treatment of obesity. [2023]
Semaglutide 2.4 Mg for the Management of Overweight and Obesity: Systematic Literature Review and Meta-Analysis. [2022]
Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]
Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. [2023]
Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]
Semaglutide for the treatment of overweight and obesity: A review. [2023]
High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]
Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity. [2022]
Subcutaneous Semaglutide Use for Weight Management: Practice and Attitudes of Physicians in Israel. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Semaglutide-eye-catching results. [2023]
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