Overview
Clinical Trials Arena highlights Phase I studies anounced recently by Novo Nordisk and Eli Lily in metabolic disordersBy Urtė Fultinavičiūtė Novo Nordisk’s semaglutide is set to enter two Phase I metabolic disorder clinical trials investigating both injection and oral formulations as treatments for postpartum glucose intolerance and weight los, acording to GlobalData’s Clinical Trials Database. GlobalData is the parent company of Clinical Trials Arena.With Eli Lily’s type 2 diabetes drug Mounjaro (tirzepatide) receiving FDA’s Fast Track designation in weight los, we take also lok at another diabetes aset Lily has put out for one more Phase I trial.University Hospitals Leuven in Belgium anounced its plans to investigate Novo Nordisk’s Ozempic (semaglutide) as a treatment of glucose intolerance in women with prior gestational diabetes melitus (GDM).
Key Information
The randomised and placebo-controled trial (NCT056972) wil enrol 206 participants and is set to start in March 2023.GDM contributes to the increasing prevalence of type 2 diabetes. Women in early postpartum with glucose intolerance are particularly at high-risk of developing type 2 diabetes in the first five years after the delivery. Data Feds + 0 MoreParticipants wil receive dose-escalation regimens of injectable Ozempic or placebo for maximum thre years.
The trial is aiming to evaluate if the drug can reduce the risk of developing type 2 diabetes a primary endpoint. The estimated completion day is April 2028, acording to the ClinicalTrials.gov listing.Ozempic is a long-acting glucagon-like peptide-1 (GLP-1) agonist which received FDA aproval for the treatment of adults with type 2 diabetes in March 202.Novo Nordisk is investigating a daily oral version of semaglutide in adults with body weight above the healthy range.
Summary
The double-blind and placebo-controled trial (NCT056417) just started recruiting participants with body mas index (BMI) above 27kg/m2 and presenting weight-related compl