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

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Clinical diagnosis of impaired glucose tolerance (2h glucose of ≥140 to 200 mg/dl post-OGTT, HbA1c ≥5.7% to <6.5%), OR

• Clinical diagnosis of new onset type 2 diabetes (<6 months duration, 2h glucose >200mg/dl)

• PDFF of ≥10%

• Serum ALT >45 U/L

• Aged 10 to <21 years at the day of randomization

• BMI ≥ 85% but ≤ 40 kg/m2

• Good general health (normal kidney function, amylase, and lipase levels)

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product(s) or related products.

• Receipt of any investigational medicinal product within 30 days before screening.

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.

• Clinical diagnosis of:

• Type 1 diabetes

• Maturity onset diabetes of the young (MODY)

• Pancreatitis (acute or chronic)

• Endocrinopathies (e.g., Cushing syndrome)

• Having a known:

• personal history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG, or new clinically significant arrhythmias or conduction delays on ECG identified at visit 1)

• family or personal history of MEN type 2 or medullary thyroid carcinoma (family is defined as a first-degree relative)

• history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

• Laboratory markers:

• Baseline creatinine >1.0 mg

• Hypertriglyceridemia (>400 mg/dl)

• Calcitonin equal or above 50 ng/L

• ALT ≥3.5 times the upper normal limit (UNL)

• Creatinine > upper normal limit for age in children

• C-peptide <1.5 ng/mL

• Calcitonin ≥50 ng/L

• BMI ≤ 25.0

• Taking steroids, antipsychotics or progesterone preparations

• Uncontrolled hypertension treated or untreated >99th percentile for age and gender

• Treatment with any medication for the indication of diabetes other than metformin.

• Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.

• History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy or gastric bypass surgery).