Novo Nordisk ’s semaglutide is set to enter two Phase III metabolic disorder clinical trials investigating both injection and oral formulations as treatments for postpartum glucose intolerance and weight loss, according to GlobalData’s Clinical Trials Database. GlobalData is the parent company of Clinical Trials Arena.

With Eli Lilly’s type 2 diabetes drug Mounjaro (tirzepatide) receiving FDA’s Fast Track designation in weight loss, we take also look at another diabetes asset Lilly has put out for one more Phase III trial.

Diabetes prevention in postpartum women

University Hospitals Leuven in Belgium announced its plans to investigate Novo Nordisk’s Ozempic (semaglutide) as a treatment of glucose intolerance in women with prior gestational diabetes mellitus (GDM). The randomised and placebo-controlled trial (NCT05569772) will enrol 206 participants and is set to start in 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.

Participants will receive dose-escalation regimens of injectable Ozempic or placebo for maximum three years. The trial is aiming to evaluate if the drug can reduce the risk of developing type 2 diabetes as a primary endpoint. The estimated completion day is April 2028, according to the ClinicalTrials.gov listing.

Ozempic is a long-acting glucagon-like peptide-1 (GLP-1) agonist which received FDA approval for the treatment of adults with type 2 diabetes in March 2022.

Wegovy goes oral

Novo Nordisk is investigating a daily oral version of semaglutide in adults with body weight above the healthy range. The double-blind and placebo-controlled trial (NCT05564117) just started recruiting participants with body mass index (BMI) above 27kg/m2 and presenting weight-related complications, such as hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease, or a BMI above 30kg/m2, which is considered obesity.

The trial aims to enrol 300 participants. Inclusion criteria also state the requirement of history of at least one self-reported unsuccessful dietary effort to lose body weight. Patients will receive dose-escalation regimens of semaglutide or placebo for 64 weeks.

The primary endpoints of the study are measuring relative change in body weight and the number of participants who achieve weight loss of five percent at the end of the treatment. The estimated completion day is May 2024, according to the ClinicalTrials.gov listing.

Novo Nordisk marketed the injectable formulation of semaglutide as Wegovy in June 2021. It was the first treatment since 2014 which received FDA approval for chronic weight management.

Basal Insulin Fc in Phase III

Eli Lilly recently registered its trial to test the effect of the injection site on the relative and absolute bioavailability of a Phase III asset LY3209590 (Basal Insulin-Fc) as a single dose. The study will be carried out in a single site and recruit only healthy volunteers in Singapore.

LY3209590 acts by agonizing the insulin receptor. The drug is being investigated as a once-weekly injection for the treatment of type 1 and 2 diabetes. LY3209590 is being tested in five ongoing Phase III trials in patients with both types of diabetes.

Earlier this year, Eli Lilly announced its plans to initiate a global and registrational Phase III study to compare LY3209590 with long-acting insulin glargine in insulin naïve patients with type 2 diabetes. The estimated start date for this trial is December 2022.