Semaglutide for Type 2 Diabetes and Fatty Liver in Youth
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Yale University
Must be taking: Metformin
Must not be taking: Antipsychotics, Steroids
Disqualifiers: Type 1 diabetes, Pancreatitis, Hypertension, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that participants have been on a stable dose of metformin for diabetes for at least 12 months or less. If you are taking other diabetes medications or medications that may cause significant weight changes, you may need to stop them before joining the trial.
What data supports the effectiveness of the drug Semaglutide for Type 2 Diabetes and Fatty Liver in Youth?
Semaglutide, a drug used for type 2 diabetes, has shown potential benefits for non-alcoholic fatty liver disease (NAFLD) in adults, as it improved the fatty liver index in a study. Additionally, Liraglutide, another drug in the same class, has been effective in improving liver enzymes and weight loss in adolescents with type 2 diabetes and fatty liver disease.
12345Is semaglutide safe for humans?
Liraglutide and semaglutide, which are similar medications, have been shown to be safe in clinical trials for treating type 2 diabetes and obesity. These medications help control blood sugar and weight, and their safety has been demonstrated in various studies.
56789How is the drug semaglutide unique for treating type 2 diabetes and fatty liver in youth?
Semaglutide is unique because it can be taken as a once-weekly injection or a once-daily oral pill, making it more convenient than many other diabetes treatments that require more frequent dosing. It also helps control blood sugar and body weight, which can be beneficial for managing type 2 diabetes and related conditions like fatty liver.
56101112Eligibility Criteria
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.Inclusion Criteria
I am between 10 and 20 years old, in puberty, and if female, not pregnant.
Your ALT levels are higher than 25 units per liter.
I weigh at least 54kg.
+6 more
Exclusion Criteria
You have had major depression, severe psychiatric disorders, or suicidal thoughts or behavior in the past 2 years.
Known or suspected hypersensitivity to trial product(s) or related products
I haven't had cancer, except for skin cancer or early-stage cancer, in the last 5 years.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Semaglutide (Wegovy) or placebo for 6 months
6 months
Monthly visits (in-person)
Wash-out
Participants undergo a 3-month wash-out period after treatment
3 months
Follow-up
Participants are monitored for safety and effectiveness after the wash-out period
3 months
Participant Groups
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.
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.
Liraglutide Pen Injector is already approved in United States, United States, European Union for the following indications:
🇺🇸 Approved in United States as Saxenda for:
- Weight management in adults and children aged 12 and older
🇺🇸 Approved in United States as Victoza for:
- Type 2 diabetes treatment in adults and children aged 10 and older
- Reducing the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease
🇪🇺 Approved in European Union as Victoza for:
- Type 2 diabetes treatment in adults and children aged 10 and older
- Reducing the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Pediatric Diabetes CenterNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Liraglutide efficacy and action in non-alcoholic steatohepatitis (LEAN): study protocol for a phase II multicentre, double-blinded, randomised, controlled trial. [2022]Non-alcoholic steatohepatitis (NASH) is now the commonest cause of chronic liver disease. Despite this, there are no universally accepted pharmacological therapies for NASH. Liraglutide (Victoza), a human glucagon-like peptide-1 (GLP-1) analogue, has been shown to improve weight loss, glycaemic control and liver enzymes in type 2 diabetes. There is currently a lack of prospective-controlled studies investigating the efficacy of GLP-1 analogues in patients with NASH.
Effect of Switching to Once-Weekly Semaglutide on Non-Alcoholic Fatty Liver Disease: The SWITCH-SEMA 1 Subanalysis. [2023]Non-alcoholic fatty liver disease (NAFLD) is an important common comorbidity in individuals with type 2 diabetes (T2DM). Although some glucagon-like peptide-1 receptor agonists (GLP-1RAs) have beneficial effects on NAFLD, the efficacy of once-weekly semaglutide has not been established. This was a subanalysis of the SWITCH-SEMA 1 study, a multicenter, prospective, randomized, parallel-group trial comparing switching from liraglutide or dulaglutide to once-weekly semaglutide in subjects with T2DM (SWITCH) versus continuing current GLP-1RAs (Continue) for 24 weeks. This subanalysis consisted of participants who were suspected to have NAFLD [fatty liver index (FLI) ≥ 30]. In total, 58 participants met the criteria of this subanalysis. There were no statistical differences in baseline characteristics between the SWITCH (n = 31) and Continue groups (n = 27). FLI significantly improved during treatment in the SWITCH group (68.6 to 62.7) but not in the Continue group (71.1 to 72.3) (p < 0.01). The improvement of FLI in the SWITCH group was greater in switching from dulaglutide to semaglutide and significantly correlated with older age (p = 0.016) and lower baseline FLI (p < 0.01). The multiple linear regression analysis revealed that the switch from dulaglutide was associated with an improvement in FLI (p = 0.041). Switching from conventional GLP-1RAs to once-weekly semaglutide might be beneficial for individuals with NAFLD complicated with T2DM.
Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial. [2023]Patients with non-alcoholic steatohepatitis (NASH)-related cirrhosis are at high risk of liver-related and all-cause morbidity and mortality. We investigated the efficacy and safety of the glucagon-like peptide-1 analogue semaglutide in patients with NASH and compensated cirrhosis.
Liraglutide with Lifestyle Intervention in Adolescents with Overweight/Obesity, Nonalcoholic Fatty Liver Disease, and Type II Diabetes Mellitus. [2023]There is a strong interplay between nonalcoholic fatty liver disease (NAFLD), obesity, insulin resistance, and type II diabetes mellitus (T2DM). Liraglutide, a glucagon-like-peptide-1 (GLP-1) analogue, is FDA approved for T2DM in children 10 years or older and more recently approved for chronic weight management in children 12 years or older with obesity. GLP-1 analogues have also been shown to reduce liver enzymes and improve liver histology. We report two adolescent females with T2DM and biopsy proven nonalcoholic steatohepatitis (NASH) refractory to lifestyle intervention who were safety treated with liraglutide with associated weight loss and liver enzyme improvement. This is the first case series reporting use of liraglutide in pediatric NASH. Liraglutide should be considered in pediatric patients with overweight/obesity, NAFLD, and T2DM.
Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]Semaglutide is an oral glucagon-like peptide receptor agonist approved in 2019 by the U.S. Food and Drug Administration. It is marketed under the brand name Rybelsus and was approved to be used in conjunction with lifestyle modifications to treat individuals with type 2 diabetes. It is the first in its drug class to be administered in a once-daily oral form. Through its actions on glucose control and body weight, this once-daily oral medication could contribute to better glycemic control and healthier lives for many women with type 2 diabetes.
[LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. [2016]Liraglutide is an analogue of Glucagon-Like Peptide-1 (GLP-1) already indicated under the trade name of Victoza for the treatment of type 2 diabetes, at usual doses of 1.2 or 1.8 mg as once daily subcutaneous injection. It is henceforth indicated at a dose of 3.0 mg, also as once daily subcutaneous injection, for the treatment of obesity or overweight with comorbidities under the trade name of Saxenda, in combination with diet and exercise. Besides a specific action on the endocrine pancreas, mainly responsible for the antihyperglycaemic effect, liraglutide helps controlling appetite at the hypothamalic level. A specific programme of controlled trials (especially SCALE studies) demonstrated both efficacy and safety of the 3.0 mg dose of liraglutide in obese or overweight patients with various comorbidities.
Liraglutide for Type 2 diabetes and obesity: a 2015 update. [2015]Subcutaneous liraglutide (Victoza(®), Novo Nordisk) was approved for the treatment of Type 2 diabetes mellitus (T2DM) in Europe in 2009 and in the USA in 2010. In December 2014, liraglutide 3.0 mg was approved by the Food and Drug Administration (FDA) and in March 2015 by the European Medicines Agency (EMA) for the treatment of chronic weight management under the brand name Saxenda(®) Novo Nordisk. Liraglutide causes a glucose-dependent increase in insulin secretion, decreases glucagon secretion and promotes weight loss by inhibiting appetite. Liraglutide probably induces satiety through activation of different areas in the hind brain and possibly by preserving free leptin levels. Recently, liraglutide has been suggested to protect against prediabetes and seems to prevent bone loss by increasing bone formation following diet-induced weight loss in obesity. This article not only covers the major clinical trials evaluating the effects of liraglutide in obesity and T2DM but also provides novel insights into the pharmacological mechanisms of liraglutide.
Liraglutide. [2021]In January 2010, liraglutide (Victoza; Novo Nordisk)--an injectable glucagon-like peptide 1 receptor agonist--was approved by the US FDA to improve glycaemic control in adults with type 2 diabetes mellitus.
Liraglutide for type 2 diabetes? [2018]Several drugs that act on the incretin hormonal system are now licensed in the UK as add-on therapy for patients with type 2 diabetes mellitus and inadequate glycaemic control. Liraglutide (Victoza--Novo Nordisk) is a recently licensed long-acting glucagon-like peptide-1 (GLP-1) mimetic that can be given once daily as a subcutaneous injection, as part of either dual or triple therapy. Advertising claims that use of the drug leads to "reductions in weight"; "reductions in systolic blood pressure"; and "improvements in beta-cell function", as well as reductions in blood glucose concentrations. Here we assess the evidence for these claims and consider whether liraglutide has a role in the management of patients with type 2 diabetes.
Liraglutide: a review of its use in type 2 diabetes mellitus. [2021]Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus. In phase III studies, once-daily subcutaneous liraglutide improved glycaemic control compared with placebo or active comparator in adult patients with type 2 diabetes, both as monotherapy and in combination with one or two oral antidiabetic drugs such as metformin, sulfonylureas or thiazolidinediones. Liraglutide provided significantly better glycaemic control than rosiglitazone or insulin glargine in combination trials. At appropriate dosages, liraglutide was noninferior to glimepiride with respect to glycaemic control in a combination trial, but provided significantly better control than glimepiride or glibenclamide in monotherapy trials. Liraglutide improved pancreatic beta-cell function, generally led to weight loss, and was associated with a low risk of hypoglycaemia. Liraglutide was generally well tolerated, with the most common adverse events being gastrointestinal events, such as nausea, which decreased over time. Thus, liraglutide is an effective treatment option for use in patients with type 2 diabetes mellitus.
Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. [2022]Semaglutide is a novel glucagon-like peptide-1 (GLP-1) analogue, suitable for once-weekly subcutaneous administration, in development for treatment of type 2 diabetes. We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Safety of injectable semaglutide for type 2 diabetes. [2022]Semaglutide is the most recently approved injectable glucagon-like peptide-1 receptor agonist (GLP-1RA) for people with type 2 diabetes (T2DM). It is one of the three currently marketed GLP-1RAs that can be administered once weekly.