GLP-1 Analogue for Obesity

Overseen By Ania Jastreboff, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: Psychiatric medications, Anti-obesity medications

Disqualifiers: Diabetes, Substance use disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new treatment, semaglutide (a GLP-1 analogue), for people with obesity. Researchers seek to determine if it can reduce cravings, hunger, stress, and overall weight compared to a placebo. Participants should have a body mass index (BMI) between 30 and 49.9 and should not have significant medical issues like diabetes. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take any psychiatric medications or anti-obesity medications. If you are on these, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide, a treatment being tested for obesity, has undergone safety studies. In some studies, participants taking semaglutide experienced stomach issues like nausea and diarrhea about 1.6 times more often than those not taking it.

On the positive side, semaglutide has been linked to favorable outcomes. It reduced hospital stays due to heart failure by 76% and lowered deaths from heart-related causes by 17%. Additionally, it helped reduce major heart-related events by 20% in a large group of adults.

While semaglutide is still being tested for obesity, its use for other conditions suggests it is generally considered safe. Joining a clinical trial is a personal choice, so weighing the pros and cons is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about Semaglutide for obesity because it uses a unique mechanism as a GLP-1 (glucagon-like peptide-1) analogue. Unlike standard treatments that often focus on appetite suppression or calorie restriction, Semaglutide mimics a hormone that regulates appetite and insulin secretion, potentially offering more effective and sustained weight loss. Additionally, it is administered via a convenient weekly injection, which can improve adherence compared to daily medications. This combination of a novel mechanism and user-friendly delivery has researchers hopeful for significant advances in obesity management.

What evidence suggests that semaglutide might be an effective treatment for obesity?

In this trial, participants will receive either semaglutide or a placebo. Research has shown that semaglutide can aid weight loss in people with obesity. One study found that individuals taking semaglutide lost an average of 14.9% of their body weight, compared to a 2.4% loss in those taking a placebo. This weight loss occurred steadily over 68 weeks. Semaglutide also reduces waist size and improves other weight-related health issues. These findings suggest that semaglutide could be a promising option for managing weight in people with obesity. ^{3 6 7 8 9}

Who Is on the Research Team?

Rajita Sinha, PhD

Principal Investigator

Psychiatry; Director Yale Stress Center

Ania Jastreboff, MD, PhD

Principal Investigator

Internal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology);

Are You a Good Fit for This Trial?

This trial is for adults with obesity (BMI of 30-49.9) who speak and read English, can consent to participate, and have no significant medical issues like diabetes or recent major weight loss. It's not for those with neurological, thyroid, cardiovascular diseases, substance use disorders including nicotine, or women who are pregnant/lactating.

Inclusion Criteria

I can speak, read, and understand English well enough to complete study tasks.

My BMI is between 30 and 49.9.

I do not have diabetes or other major health issues.

Exclusion Criteria

I have lost more than 10% of my body weight in the last 6 months or am actively participating in a weight loss program.

I have or had alcohol, substance use disorders, or psychiatric conditions.

I have no major health issues like heart, kidney, liver diseases, or diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 analogue (semaglutide) or placebo weekly for 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Semaglutide

Trial Overview The study tests a GLP-1 analogue drug called semaglutide against a placebo in people with obesity. It aims to see if the drug affects cravings for food, feelings of hunger and stress levels differently than the placebo and whether it leads to weight loss.

How Is the Trial Designed?

Group I: GLP-1a Experimental Treatment 1 Intervention

GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo pen administered weekly over 12 weeks

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. vox.com vox.com/future-perfect/467025/ozempic-glp-1-drugs-obesity-weight-loss

The Ozempic effect is finally showing up in obesity data - Vox The magic injection. What's changed is we now have highly effective weight-loss medicines working at a scale that we've never seen before.

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

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10092086/

Semaglutide for the treatment of overweight and obesity Semaglutide 2.4 mg was associated with mean weight losses of 14.9%‐17.4% in individuals with overweight or obesity without type 2 diabetes from baseline to ...

4. nature.com nature.com/articles/s41591-025-03978-z

A systematic review and meta-analysis of the efficacy and ... Weight regain after discontinuation of semaglutide and tirzepatide treatment for 52 weeks was 67% and 53%, respectively. Waist circumference, ...

5. novomedlink.com novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/chronic-weight-management.html

Chronic Weight Management Trial Results | Wegovy ... Patients taking Wegovy® 2.4 mg experienced improvements across most cardiometabolic risk factors · Wegovy® is not indicated to treat hypertension, type 2 ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ... A primary cardiovascular end-point event occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and in 701 of the 8801 patients (8.0%) in the ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39396098/

Semaglutide effects on safety and cardiovascular ... Conclusion: The use of semaglutide reduced 76% in hospitalization due to HF, 17% deaths due to cardiovascular causes, 21% deaths due to any ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9758543/

Efficacy and Safety of Semaglutide for Weight Loss in ... Secondary outcomes showed that the risk of developing gastrointestinal adverse events was 1.59 times more likely with semaglutide (RR 1.59, 95%CI [1.34, 1.88], ...

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

Long-term weight loss effects of semaglutide in obesity ... In the SELECT cardiovascular outcomes trial, semaglutide showed a 20% reduction in major adverse cardiovascular events in 17,604 adults with ...