Semaglutide for Obesity

Recruiting at 1 trial location

Overseen By Megan Schaefer

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Anti-obesity, GLP1R agonists

Disqualifiers: Bariatric surgery, Untreated psychiatric, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a saliva-based test might predict responses to semaglutide, a medication for obesity. Participants will receive either semaglutide or a placebo (a substance with no active drug) weekly for 24 weeks. The trial seeks individuals with obesity who have not experienced significant recent weight changes and do not have untreated psychiatric issues. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for semaglutide?

Research shows that semaglutide is generally safe and well-tolerated. Studies have found that semaglutide aids weight loss in individuals who are overweight or obese, with participants losing more weight than those on a placebo.

Regarding safety, semaglutide has proven safe for people without diabetes who are overweight or obese. It has been used for an extended period, and many individuals have tolerated it well. While some may experience mild nausea, the overall safety profile is considered good. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard obesity treatments that often involve lifestyle changes, medications like orlistat, or surgeries, Semaglutide offers a different approach. Researchers are excited about Semaglutide because it is a GLP-1 receptor agonist, originally used for diabetes management, that also helps regulate appetite and food intake, leading to significant weight loss. This treatment is administered via a simple weekly injection, providing a convenient and effective alternative to daily medications or invasive procedures. With its dual action on blood sugar levels and appetite control, Semaglutide has the potential to revolutionize obesity management.

What is the effectiveness track record for semaglutide in treating obesity?

Research has shown that semaglutide aids weight loss in individuals with obesity. In one study, participants taking semaglutide for 208 weeks lost an average of 10.2% of their body weight. Another study found that weekly semaglutide, combined with lifestyle changes, led to significant weight loss. In a group study, patients lost 5.9% of their body weight after 3 months and 10.9% after 6 months. A review also found that semaglutide supports long-term weight loss in adults who are overweight or obese. In this trial, participants in the Semaglutide Group will take semaglutide weekly for 24 weeks to evaluate its effectiveness. Overall, semaglutide offers a reliable option for reducing body weight in these groups. ^{1 4 5 6 7}

Who Is on the Research Team?

Andres Acosta, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Semaglutide Group Experimental Treatment 1 Intervention

Subjects will take semaglutide weekly for 24 weeks

Group II: Placebo Group Placebo Group 1 Intervention

Subjects will take placebo weekly for 24 weeks.

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+

Published Research Related to This Trial

A survey of 127 physicians revealed that many have varying pre-treatment requirements for prescribing semaglutide for weight loss, with 30% requiring a minimum body mass index of 30 kg/m² and 67% expecting documented lifestyle changes.

Despite its effectiveness, over 50% of patients discontinued semaglutide therapy within the first 3 months, primarily due to cost, perceived lack of effectiveness, and concerns about long-term side effects, indicating a need for better patient education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Semaglutide Use for Weight Management: Practice and Attitudes of Physicians in Israel. Dicker, D., Tamir, O., Lieberman-Segal, G., et al.[2023]

In a study involving 2117 participants treated with semaglutide 2.4 mg for 68 weeks, gastrointestinal adverse events (AEs) like nausea and diarrhea were more common than in the placebo group, but these AEs were mostly mild and transient, with only 4.3% of participants discontinuing treatment due to them.

Weight loss with semaglutide was significant and similar in participants with and without GI AEs, indicating that the weight loss effects of semaglutide are largely independent of these gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wharton, S., Calanna, S., Davies, M., et al.[2022]

In a phase 3 trial involving 667 adults with overweight or obesity, oral semaglutide 50 mg taken daily resulted in a significant average weight loss of 15.1% compared to only 2.4% with placebo over 68 weeks, demonstrating its efficacy in weight management.

While semaglutide was effective, it was associated with a higher incidence of adverse events, particularly gastrointestinal issues, affecting 80% of participants, indicating that while it is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Knop, FK., Aroda, VR., do Vale, RD., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

In the STEP clinical trial program, participants with obesity who received once-weekly semaglutide 2.4 mg experienced significant weight loss, averaging between 14.9% and 17.4% over 68 weeks, with 69%-79% achieving at least 10% weight loss compared to only 12%-27% with placebo.

Semaglutide 2.4 mg also led to improvements in cardiometabolic risk factors and had a consistent safety profile, primarily involving gastrointestinal side effects, indicating its potential as an effective treatment for obesity and related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of overweight and obesity: A review. Bergmann, NC., Davies, MJ., Lingvay, I., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a cohort study of 408 adults with obesity, those treated with weekly semaglutide injections (1.7 mg or 2.4 mg) experienced significant weight loss, averaging 5.9% after 3 months and 10.9% after 6 months, which aligns with results from randomized clinical trials.

The majority of patients (87.3%) achieved at least 5% weight loss after 6 months, although those with type 2 diabetes experienced less weight loss compared to those without diabetes, indicating that diabetes status may influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity. Ghusn, W., De la Rosa, A., Sacoto, D., et al.[2022]

Semaglutide, approved by the FDA on June 4, 2021, is the first new drug for chronic weight management in adults with obesity or overweight since 2014, specifically targeting those with a BMI of 27 or greater and at least one weight-related condition.

This medication is intended to be used alongside a weight management program that includes a reduced-calorie diet and increased physical activity, highlighting its role as part of a comprehensive approach to weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Mares, AC., Chatterjee, S., Mukherjee, D.[2023]

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Qin, W., Yang, J., Deng, C., et al.[2023]

High-dose once-weekly semaglutide has been shown to significantly reduce weight in patients with obesity or overweight, as demonstrated in four phase 3 clinical trials involving various populations, including those with diabetes.

While gastrointestinal side effects were common, semaglutide was generally well tolerated and also led to improvements in cardiometabolic risk factors, such as waist circumference and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Semaglutide, a glucagon-like peptide-1 receptor agonist, is effective for treating type 2 diabetes and obesity, providing significant weight loss and cardiovascular benefits, making it crucial for high-risk patients.

However, during the SUSTAIN clinical trial program, a safety concern arose regarding the worsening of diabetic retinopathy, potentially linked to rapid reductions in HbA1c levels, which requires further investigation and careful clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide-eye-catching results. Cigrovski Berkovic, M., Strollo, F.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38740993/

Long-term weight loss effects of semaglutide in obesity ... At 208 weeks, semaglutide was associated with mean reduction in weight (-10.2%), waist circumference (-7.7 cm) and waist-to-height ratio (-6.9%) ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2032183

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.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2796491

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.

4. ajconline.org ajconline.org/article/S0002-9149(24)00319-9/fulltext

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.

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15386

Efficacy and safety of semaglutide 2.4 mg for weight loss in ... Pooled data showed that subcutaneous semaglutide 2.4 mg, administered once a week, resulted in a significantly larger decrease in BMI compared ...

6. nature.com nature.com/articles/s41591-024-02996-7

Long-term weight loss effects of semaglutide in obesity ... Semaglutide produced clinically significant weight loss and improvements in anthropometric measurements versus placebo. Weight loss was sustained over 4 years.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11613982/

Effectiveness and safety of semaglutide in overweight/obese ... The results revealed that semaglutide was more effective than placebo or other hypoglycemic drugs in reducing body weight, BMI, and waist ...