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GLP-1 Receptor Agonist
Semaglutide for Type 2 Diabetes and Fatty Liver in Youth
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
Must not have
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods
Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
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.
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 belowSelect...
I weigh at least 54kg.
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My BMI is between 85% percentile and 40 kg/m2.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, planning to become pregnant, or if of childbearing potential, I am using effective contraception.
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I haven't taken diabetes medication not listed in the criteria in the last 90 days.
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You have Type 1 diabetes, MODY, pancreatitis, endocrine disorders, significant heart disease, or any other condition that could affect your safety during the study.
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I have not started puberty (Tanner stage 1).
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My child has very high blood pressure that isn't controlled.
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I have positive IA-2 or anti-GAD antibodies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Oral Disposition Index (oDI)
Secondary study objectives
Change in OGTT derived biomarkers: c-peptide
Change in OGTT derived biomarkers: fasting c-peptide
Change in OGTT derived biomarkers: fasting insulin
+10 moreOther study objectives
Changes in liver fibrosis
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: 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.
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,414 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
903 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,393 Total Patients Enrolled
57 Trials studying Non-alcoholic Fatty Liver Disease
10,162 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sonia Caprio, MDPrincipal InvestigatorYale University
10 Previous Clinical Trials
3,958 Total Patients Enrolled