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

96 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests semaglutide, a medication that helps reduce appetite, in adults with obesity. It aims to see if the drug can help reduce food cravings, hunger, stress, and lead to weight loss by making people feel fuller and less hungry. Semaglutide has been widely studied and approved for chronic weight management in adults with obesity.

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);

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+