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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, 4, 8, 12
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with obesity lose weight by reducing hunger, cravings, and stress.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Craving
Change in Food Intake
Change in Hunger
Secondary outcome measures
Change in food intake - real-life
Change in stress
Change in weight

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

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,345 Total Patients Enrolled
59 Trials studying Obesity
248,052 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,496 Total Patients Enrolled
446 Trials studying Obesity
588,842 Patients Enrolled for Obesity
Ania Jastreboff, MD, PhDPrincipal InvestigatorInternal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology);

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04779697 — Phase 1
Obesity Research Study Groups: GLP-1a, Placebo
Obesity Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04779697 — Phase 1
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04779697 — Phase 1
Obesity Patient Testimony for trial: Trial Name: NCT04779697 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How might I participate in this research endeavor?

"Patients aged 18 to 55, who possess a BMI between 30 and 49.9 kg/m2 with no major medical problems such as diabetes or HgbA1c <6.5% are eligible for this study of 96 participants that aims to better understand obesity. In order to participate in the trial, each individual must provide both written and verbal consent."

Answered by AI

In what types of conditions is semaglutide, a GLP-1 analogue, regularly prescribed?

"Semaglutide, a GLP-1 analogue, is the most effective method for treating chronic weight management. Furthermore, this medication may help patients with comorbid conditions who are on reduced-calorie diets and exercising regularly to reach their health goals."

Answered by AI

How many people have thus far enrolled in this medical experiment?

"That is correct. Clinicaltrials.gov verifies that the trial, which was initially published on February 1st 2021, is actively recruiting for 96 patients across one medical site."

Answered by AI

Is semaglutide recognized by the FDA as a GLP-1 analogue?

"The safety of semaglutide as a GLP-1 analogue is minimally understood, thus receiving the lowest score of 1 according to our team at Power. This reflects its status as an early phase trial with limited clinical evidence for efficacy and safety."

Answered by AI

Is this research protocol accommodating minors?

"Individuals aged 18 and over, but under 55 years old are eligible to apply for this clinical trial."

Answered by AI

Has semaglutide been subjected to any other clinical examination?

"At present, 58 different medical studies are being conducted on GLP-1 analogue - semaglutide. 27 of those trials have advanced to Phase 3. Primarily based in Loma Linda, California, this drug is also undergoing testing at 3907 other locations worldwide."

Answered by AI

Is this particular experiment unique in its approach?

"Since 2018, the GLP-1 analogue semaglutide has undergone clinical testing. Initially sponsored by Novo Nordisk A/S and involving 1387 participants in its first trial, this drug was granted Phase 4 approval. Currently there are 58 active studies for semaglutide spread across 55 countries and 772 cities."

Answered by AI

Is enrollment into this trial currently available to participants?

"According to online records, this clinical trial commenced on February 1st 2021 and remains open for recruitment. The study was last amended on July 25th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
New York
How old are they?
18 - 65
What site did they apply to?
The Yale Stress Center: Yale University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

just wondering how to get the saxenda. I’ve tried other over the counter weight loss aids but nothing worked. I’m interested in trying new drugs or technologies that might prove to help me lose my belly fat.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
2021. "GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04779697.
~16 spots leftby Jan 2025
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