Novo Nordisk Announces Topline Results for Amycretin as Potential Obesity, Overweight Treatment

Amycretin (Novo Norisk) led to a reduction in body weight across the 20-week, 28-week, and 36-week periods, with weight loss of up to 22%, according to results from a randomized control trial.¹

Amycretin (Novo Norisk) led to a reduction in body weight loss across various time points. | Image Credit: alones | stock.adobe.com

“We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity,” Martin Lange, executive vice president for development at Novo Nordisk, said in a news release. “The results seen in the trial support the weight-lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist, amycretin, that we have previously seen with the oral formulation.”¹

Amycretin is similar to the amylin and glucagon-like peptide-1 hormones. Investigators of the study aimed to determine whether the study medication was safe in humans and how exactly it worked. Further, the investigators evaluated the medication’s effects on the body and how it could improve treatment of overweight, obesity, and related diseases.²

The study was split into 4 parts: parts A, B, C, and D. Part A consisted of 5 groups of 8 individuals, with 6 individuals assigned a single treatment with NC0487-0111 A (amycretin) and 2 receiving the placebo. In part B, there were 3 groups with 12 individuals; 9 who received NC0487-0111 A and 3 who received the placebo daily for 10 days. For one group, the investigators followed dosing of 4 individuals (3 active and 1 placebo) with a safety observation period of 7 days before the other participants were dosed. The remaining groups had a safety observation period for at least 36 hours for 4 patients (3 active and 1 placebo) before subsequent dosing of patients.²

Parts C and D were matched for planned visits and procedures, but the study intervention in part D differed from A, B, and C. Both parts C and D consisted of one group of 20 individuals with 16 receiving the active treatment and 4 receiving the placebo once daily for 12 weeks. The dosing pattern remained in the consistent, sequential pattern as the previous parts, and included an observation of at least 36 hours before the remaining participants were dosed. The remaining individuals were dosed in smaller groups of 8 with at least 36 hours of observation.²

For parts A and B, individuals were aged 18 to 55 years with a body mass index (BMI) of approximately 25 to 34.9 kg/m². For parts C and D, participants were in the same age range but had a BMI of 27 to 39.9 kg/m².²

The primary outcome included number of treatment emergent adverse events (AEs), and investigators reported that the safety profile of the drug was consistent with incretin-based therapies. The most common AEs were gastrointestinal and were mild to moderate in severity.¹

Investigators reported that treatment with amycretin showed an estimated weight loss of 9.7% on 1.25 mg of the subcutaneous injection (20 weeks), 16.2% on 5 mg (28 weeks) and 22% on 20 mg (36 weeks). Further, those treated with the placebo had a body weight gain of 1.9%, 2.3%, and 2%, respectively.¹

Based on the results, Novo Nordisk is planning further clinical developments for the drug in adults with obesity and overweight.¹

REFERENCES

1. Novo Nordisk successfully completes phase 1b/2a trial with subcutaneous amycretin in people with overweight or obesity. News release. Novo Nordisk. January 24, 2025. Accessed January 24, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=915251

2. A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity. ClinicalTrials.gov ID: NCT05369390. Updated July 3, 2024. Accessed January 24, 2025. https://clinicaltrials.gov/study/NCT05369390