▎WuXiEdited by Kant Content Team

Novo Nordisk announced detailed trial results of its oral GLP-1 and amylin long-acting co-agonist, amycretin, in the abstracts for the upcoming 2024 European Association for the Study of Diabetes (EASD) annual meeting. Analysis shows,At 12 weeks of the trial, the highest dose was administered.The body weight of amycretin subjects decreased by up to 13.1%, and the subjects' weight loss has not yet reached a plateau.Based on these positive results, Novo Nordisk willFurther development of amycretin.

The phase 1 trial announced this time is a "first-in-human," single-center, placebo-controlled, double-blind study. Participants were randomly assigned to receive either once-daily oral amycretin (n=95) or placebo (n=29). These participants did not have diabetes and had a body mass index (BMI) ranging from 25.0-39.9 kg/m²The study was divided into three parts: single ascending dose (Part A, 1-25 mg), multiple ascending doses over 10 days (Part B, 3-12 mg), and multiple ascending doses over 12 weeks (Part C, 3-2×50 mg). The primary endpoint was the number of treatment-emergent adverse events (AEs), with secondary endpoints including the area under the curve (AUC) and mean maximum plasma concentration (Cmax) of amycretin. Changes in baseline body weight were assessed as a key exploratory endpoint.

The analysis shows,At week 12, the mean change in body weight in the amycretin group (50 mg, -10.4% [SD=4.6]; 2×50 mg, -13.1% [SD=4.8]) was significantly greater than that in the placebo group (-1.1% [SD=2.6]; both doses p<0.0001).It is worth mentioning that,Not observedWeight Loss of SubjectsThe emergence of a plateau indicates that patients may achieve further weight loss by extending treatment.

▲AWeight loss effect of mycretin in Phase 1 trials (Image source: Reference [1])

Most of the reported adverse events were mild to moderate, primarily gastrointestinal discomfort (such as nausea and vomiting) and decreased appetite.These adverse events are dose-related, with poor tolerability observed at single doses ≥18 mg and continuous dosing for 10 days at ≥12 mg.However, through gradual dose escalation, all tested dose levels (including 2×50 mg) demonstrated acceptable safety and tolerability.

Industry media Fierce Biotech previously reported that the completed STEP-1 clinical trial results showed that patients in the semaglutide group experienced a 14.9% reduction in body weight over the 68-week trial period. Although results between different clinical trials are difficult to compare directly, the rapid weight loss effect demonstrated by amycretin in Phase 1 trial results highlights the significant potential of the drug. Novo Nordisk is currently planning larger and longer-term studies to comprehensively evaluate the efficacy and safety of amycretin.Among them, the phase 2 trial examining the subcutaneous injection formulation of this therapy is currently recruiting patients.

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References:

[1] Safety, tolerability and weight reduction findings of oral amycretin: a novel amylin and glucagon-like peptide-1 receptor co-agonist, in a first-in-human study. Retrieved July 8, 2024 from https://cattendee.abstractsonline.com/meeting/20620/presentation/846

[2] Another day, another win for Novo in obesity, as early oral med appears to beat Wegovy. Retrieved March 7, 2024 from https://www.fiercebiotech.com/biotech/another-day-another-win-novo-obesity-early-oral-med-beats-wegovy

[3] A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin. Retrieved July 8, 2024 fromhttps://clinicaltrials.gov/study/NCT06064006?intr=NNC0487-0111%20A&aggFilters=phase:2&rank=1

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