On the heels of Terns’ positive Phase I results that analysts compared with Lilly’s and Pfizer’s weight loss pills in development, Novo Nordisk showcased more details about its own oral candidate.
Novo Nordisk is part of a tight battle for the next phase of the obesity market: a weight loss pill. On a week when a small biotech competitor revealed competitive weight loss data for an oral GLP-1 therapy, the Danish pharma unveiled more about the 13% weight loss achieved by its rival therapy amycretin.
Presented at the European Association for the Study of Diabetes (EASD), Novo said that this 13% weight loss, achieved at week 12 by patients who received the investigational pill, was “significantly greater” than the mean change in body weight seen among placebo recipients. The investigators called the results “remarkable” in the EASD abstract, also noting the patients did not seem to plateau, which means further reductions could occur over a longer timeframe.
Novo’s data comes days after small biotech Terns Pharmaceuticals announced that its rival pill TERN-601 achieved weight loss of 4.9% in 28 days in a Phase II trial. BMO Capital Markets analysts compared these data to results from Eli Lilly’s orforglipron, which has achieved 3.9% weight loss in a similar study, and Pfizer’s danuglipron, which led to 5.2% weight loss.
The 13% weight loss seen among patients on Novo’s amycretin had already been revealed at the company’s investor day in March, but investigators provided some more detail in the full conference presentation on Tuesday.
The small study featured patients with a BMI of 25 to 39 without diabetes who received either amycretin or placebo once a day. While the main goal was focused on recording treatment-emergent adverse events, a secondary endpoint provided a glimpse at the therapy’s weight loss potential.
On the main endpoint, Novo reported that adverse events for the amylin and GLP-1 receptor co-agonist were mostly mild to moderate. The most common were gastrointestinal discomfort such as nausea or vomiting and decreased appetite. The events were dose dependent, so those on a higher dose had low tolerability initially. Novo introduced a stepwise dose escalation, which led to an acceptable safety and tolerability profile, according to the abstract.
The investigators said longer and larger studies are being planned to further explore amycretin’s potential.
Amycretin is a key part of Novo’s obesity pipeline, which also includes the combo therapy CagriSema, for which Phase III results are expected in the second half of 2024. The company also has a wide-ranging clinical program for approved therapy semaglutide, which is marketed as Wegovy for weight loss and Ozempic for diabetes.