What is the mechanism of action of this treatment?

GLP-1 receptor agonists, such as liraglutide and semaglutide, are common treatments for obesity that mimic the GLP-1 hormone. They enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety. These mechanisms help reduce food intake and improve glycemic control, making them effective for weight loss and metabolic health. This comprehensive approach is crucial for obesity patients as it addresses both weight management and associated comorbidities.

What side effects are associated with this type of intervention?

Common side effects of GLP-1 receptor agonists, which are used to treat obesity, include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. These symptoms are typically more pronounced at the beginning of the treatment and may decrease over time. Other potential side effects include an increased risk of pancreatitis, gallbladder disease, and, in rare cases, thyroid C-cell tumors. Patients may also experience injection site reactions and, less commonly, allergic reactions. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits of the treatment outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity, including liraglutide and semaglutide. Liraglutide, administered daily, has shown significant weight loss in clinical trials, with patients losing more weight compared to placebo and orlistat. Semaglutide, another GLP-1 receptor agonist, has also demonstrated substantial weight reduction. These medications work by enhancing insulin secretion, inhibiting glucagon release, slowing gastric emptying, and promoting satiety, making them effective for weight management in patients with obesity.

What other types of research exist?

Promising novel alternatives to GLP-1 analogues for obesity treatment include: 1) Ghrelin receptor antagonists, which block orexigenic signals to reduce food intake and promote weight loss. 2) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown greater efficacy in weight loss compared to GLP-1 analogues alone. 3) Semaglutide, a long-acting GLP-1 receptor agonist, which has demonstrated significant weight loss in clinical trials and is administered once weekly. These alternatives offer different mechanisms and potential benefits for obesity management.

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GLP-1 Analogue for Obesity

Phase 1

Recruiting

Led By Ania Jastreboff, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaking and able to read English and complete study evaluations

BMI ranging from 30-49.9 kg/m2

Must not have

Current active participation in a weight loss program or weight loss of >10% of total body weight during the prior 6 months

Any significant current medical conditions, including neurological, renal, thyroid, cardiovascular, liver, endocrine or immune conditions, including diagnosis of T2DM or T1DM by American Diabetes Association (ADA) criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, 4, 8, 12

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Semaglutide may cause digestive issues such as nausea or constipation, headaches, fatigue and possible low blood sugar reactions. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My BMI is between 30 and 49.9.

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I do not have diabetes or other major health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a history of pancreatitis, thyroid cancer, or MEN syndrome, and I am not pregnant, breastfeeding, or going through menopause.

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I am not taking any other weight loss medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, 4, 8, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, 4, 8, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, 4, 8, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Craving

Change in Food Intake

Change in Hunger

Secondary study objectives

Change in food intake - real-life

Change in stress

Change in weight

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GLP-1aExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Placebo pen administered weekly over 12 weeks

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as liraglutide and semaglutide, are common treatments for obesity that mimic the GLP-1 hormone. They enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety. These mechanisms help reduce food intake and improve glycemic control, making them effective for weight loss and metabolic health. This comprehensive approach is crucial for obesity patients as it addresses both weight management and associated comorbidities.