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

Launched by YALE UNIVERSITY · Sep 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Semaglutide on young people who are overweight and have conditions like prediabetes, new-onset Type 2 diabetes, and non-alcoholic fatty liver disease (NAFLD). The goal is to see if this medication can help improve their blood sugar levels and reduce fat in the liver, which can be important for their overall health. The trial is currently recruiting participants aged 10 to under 21 years who meet specific health criteria, such as having certain blood sugar levels and being in a healthy range of weight.

If your child is eligible and decides to participate, they will receive the study medication and will be closely monitored by healthcare professionals. They will need to follow the study guidelines, which include measuring their blood sugar levels regularly. It's important to know that participants will need consent from a parent or guardian, and they'll also have to agree to the study's requirements. This trial aims to find new ways to help young people manage their health conditions and improve their quality of life.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Subjects diagnosed with Pre-impaired glucose tolerance (pre-IGT) (2h glucose ≥ 130 mg/dl to ≤ 200 mg/dl post-OGTT) OR impaired glucose tolerance (2h glucose ≥140 to \<200 mg/dl post-OGTT OR HbA1c ≥5.7% to \<6.5%), OR new-onset T2D (≤24 months duration, 2h glucose \>200 and HbA1c \>6.5% to10%) treated with stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 12 months or less)
• • PDFF of ≥ 8%
• • Male or female, aged 10 to \<21 years at the day of randomization, in puberty (pubertal stage will be assessed by pediatric Endocrinologists Dr. Samuels and Dr. Hu) (girls and boys: Tanner stage II-IV); girls who begin menstruating must have a negative pregnancy test during the study
• • Weight ≥ 54kg
• • BMI ≥ 85% but ≤ 40 kg/m2
• • Good general health (normal kidney function, amylase, and lipase levels)
• • Informed consent from a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities (trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial)
• • Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol.
• • Exclusion Criteria
• • Known or suspected hypersensitivity to trial product(s) or related products.
• • Receipt of any investigational medicinal product within 30 days before screening.
• • Prepubertal participants (Tanner stage 1)
• • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.
• * Having a diagnosis of:
• • Type 1 diabetes o Maturity onset diabetes of the young (MODY) o History or presence of Pancreatitis (acute or chronic) o Presence of endocrinopathies (e.g., Cushing syndrome) o Cardiac, renal or pulmonary or other chronic illness o Known 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) o Family or personal history of MEN type 2 or medullary thyroid carcinoma (family is defined as a first-degree relative)o Any other disorder which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
• • Any laboratory safety parameter at screening outside the below extended laboratory ranges: o Baseline creatinine \>1.0mg o Hypertriglyceridemia)(\>500 mg/dl)
• • Calcitonin equal or above 50 ng/L at screening o Body Mass Index (BMI) ≤ 25.0 at the screening visit o ALT ≥5 times the upper normal limit (UNL) o Creatinine \>UNL for age in children unless renal function is proven normal by further assessments at the discretion of the investigator
• • Known hypoglycemic unawareness.
• • Recurrent severe hypoglycemic episodes within the last year as judged by the investigator.
• • Uncontrolled hypertension treated or untreated \>99th percentile for age and gender in children and adolescents.
• • Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening.
• • Taking medication, based on the investigator's judgement, that may cause significant weight gain or loss (e.g., antipsychotic, steroid, anti-obesity medication).
• • Presence or 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.
• • Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
• Mental health:
• • History of major depressive disorder within 2 years before screening
• • Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)
• • A Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at screening
• • A lifetime history of suicidal attempt
• • Suicidal behavior within 30 days before screening
• • Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity
• • Rating Scale (C-SSRS) within the past 30 days before screening
• • Participants with confirmed diagnosis of bulimia nervosa disorder