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GLP-1 Receptor Agonist

Semaglutide for Type 2 Diabetes and Fatty Liver in Youth

Q: Does this experimental research accept elderly participants?

This trial is reserved for individuals aged 10 to 21, while there are 353 clinical trials targeting those below 18 years old and 1531 studies focusing on geriatric patients.

Q: How many participants are allowed to partake in this research trial?

Affirmative. According to the clinicaltrials.gov records, this investigation is currently in search of enrollees and was initially posted on July 17th 2023. The most recent update occurred on September 11th 2023, and it requires 60 volunteers from a single location.

Q: Is this clinical research currently accepting participants?

Affirmative. On clinicaltrials.gov, the information clearly states that this medical study is still recruiting patients after first being posted on July 17th 2023 and amended most recently on September 11th 2023. The project requires 60 individuals from 1 location to participate in it.

Q: Who fulfills the criteria to participate in this medical experiment?

This trial is looking for 60 candidates who suffer from childhood <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a> and meet the age criteria of 10 to 21.

Q: How risk-free is the Receive treatment process for patients?

Receive treatment has been evaluated to be of a Level 2 safety rating, as this is Phase 2 trial data which includes some information regarding its security but does not offer any evidence about its effectiveness.

Phase 2

Recruiting

Led By Sonia Caprio, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Weight ≥ 54kg

BMI ≥ 85% but ≤ 40 kg/m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Study Summary

This trial investigates how GLP-1 hormones affect diabetes and nonalcoholic fatty liver disease in young people.

Who is the study for?

This trial is for obese youths aged 10 to <21 with prediabetes or new-onset type 2 diabetes and non-alcoholic fatty liver disease. They must be in puberty, have a BMI between the 85th percentile and ≤40 kg/m², and elevated liver enzymes. Participants need to be able to self-monitor blood glucose, not pregnant or planning pregnancy without effective contraception, not on certain other medications, and generally healthy.Check my eligibility

What is being tested?

The study tests Semaglutide Pen Injector against a placebo in managing obesity-related complications like type 2 diabetes and fatty liver disease in young people. It aims to see if this medication can help preserve insulin-producing cell function and reduce fat in the liver.See study design

What are the potential side effects?

Semaglutide may cause digestive issues such as nausea or vomiting, potential low blood sugar events especially when combined with other diabetes drugs like metformin, headaches, fatigue, decreased appetite which could lead to weight loss.

Eligibility Criteria

Inclusion Criteria

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

Select...

I weigh at least 54kg.

Select...

My BMI is between 85% percentile and 40 kg/m2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months 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 Oral Disposition Index (oDI)

Secondary outcome measures

Change in OGTT derived biomarkers: c-peptide

Change in OGTT derived biomarkers: fasting c-peptide

Change in OGTT derived biomarkers: fasting insulin

+10 more

Other outcome measures

Changes in liver fibrosis

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Receive treatmentExperimental Treatment1 Intervention

Semaglutide (Wegovy) pen is a subcutaneous injection

Group II: PlaceboPlacebo Group1 Intervention

The placebo pen is almost exactly the same as the Wegovy subcutaneous injection except it does not contain the active ingredient, Semaglutide.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,501 Total Patients Enrolled

5 Trials studying Non-alcoholic Fatty Liver Disease

659 Patients Enrolled for Non-alcoholic Fatty Liver Disease

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

2,359 Previous Clinical Trials

4,314,532 Total Patients Enrolled

46 Trials studying Non-alcoholic Fatty Liver Disease

9,912 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Sonia Caprio, MDPrincipal InvestigatorYale University

10 Previous Clinical Trials

3,458 Total Patients Enrolled

Frequently Asked Questions

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

Does this experimental research accept elderly participants?

"This trial is reserved for individuals aged 10 to 21, while there are 353 clinical trials targeting those below 18 years old and 1531 studies focusing on geriatric patients."

Answered by AI

How many participants are allowed to partake in this research trial?

"Affirmative. According to the clinicaltrials.gov records, this investigation is currently in search of enrollees and was initially posted on July 17th 2023. The most recent update occurred on September 11th 2023, and it requires 60 volunteers from a single location."

Answered by AI

Is this clinical research currently accepting participants?

"Affirmative. On clinicaltrials.gov, the information clearly states that this medical study is still recruiting patients after first being posted on July 17th 2023 and amended most recently on September 11th 2023. The project requires 60 individuals from 1 location to participate in it."

Answered by AI

Who fulfills the criteria to participate in this medical experiment?

"This trial is looking for 60 candidates who suffer from childhood obesity and meet the age criteria of 10 to 21."

Answered by AI

How risk-free is the Receive treatment process for patients?

"Receive treatment has been evaluated to be of a Level 2 safety rating, as this is Phase 2 trial data which includes some information regarding its security but does not offer any evidence about its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease

Sonia Caprio 2023. "Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067621.

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