amycretin subcutaneous (NN9487 SC) / Novo Nordisk - LARVOL DELTA

Amycretin, a Novel, Unimolecular GLP-1 and Amylin Receptor Agonist—Results of a Phase 1b/2a Clinical Trial (ADA 2025) - P2 | "In people with overweight or obesity, once-weekly SC amycretin up to 60 mg demonstrated a safety and tolerability profile consistent with GLP-1 and amylin agonists, and led to significant, dose-dependent body weight reductions."

Clinical • Late-breaking abstract • P1/2 data • Metabolic Disorders • Obesity

Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. (PubMed, Lancet) - P2 | "In people with overweight or obesity, once-weekly subcutaneous amycretin up to 60 mg had a safety and tolerability profile consistent with GLP-1 and amylin agonists. Although a high frequency of gastrointestinal events was reported, rates were similar to those seen in early-phase studies of these molecules. These results support further investigation into the weight loss properties of amycretin."

Journal • P1/2 data • Genetic Disorders • Obesity

Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The Lancet (Novo Nordisk Press Release) - P1b/2a | N=125 | NCT06064006 | Sponsor: Novo Nordisk A/S | "Results from the phase 1b/2a trial of subcutaneous amycretin showed treatment-emergent adverse events (TEAEs) were mild or moderate in severity and increased in frequency in a dose-dependent manner....Compared to placebo, participants receiving amycretin observed greater weight loss across the full range of doses investigated. Subcutaneous amycretin at multiple doses demonstrated greater weight reduction than placebo at the end of the trial. Participants who received the highest doses (up to 60 mg) reported body weight reductions of up to 24.3% versus 1.1% with placebo after 36 weeks of treatment....Novo Nordisk will advance...subcutaneous...amycretin formulations straight to phase 3 development for weight management based on these and other completed clinical studies, as well as feedback received from regulatory authorities."

New P3 trial • P1/2 data • Obesity

Novo Nordisk plans to start late-stage trials of obesity drug amycretin next year (Yahoo Finance) - "Novo Nordisk said on Thursday it plans to start late-stage trials of its experimental weight-loss drug, amycretin, in injection and oral forms during the first quarter of 2026 for adults who are overweight or obese. The decision to advance the trials is based on feedback received from regulatory authorities in interactions following the end of its mid-stage trials, the company said. Amycretin, the Danish drugmaker's next-generation obesity drug, has a dual-mode action. Like its popular weight-loss drug Wegovy, amycretin not only mimics the gut hormone GLP-1, but also the effect of a hunger-suppressing pancreatic hormone called amylin."

New trial • Obesity

A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Long-acting Reversible Contraceptives • Obesity

A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Renal Disease • Type 2 Diabetes Mellitus

A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Long-acting Reversible Contraceptives • Obesity

Novo Nordisk successfully completes phase 1b/2a trial with subcutaneous amycretin in people with overweight or obesity (GlobeNewswire) - P1b/2a | N=125 | NCT06064006 | Sponsor: Novo Nardisk A/S | "Novo Nordisk today announced topline results from a phase 1b/2a clinical trial with amycretin...The primary endpoint was treatment emergent adverse events. The safety profile of amycretin was consistent with incretin-based therapies. The most common adverse events with amycretin were gastrointestinal and the vast majority were mild to moderate in severity. When evaluating the effects of treatment if all people adhered to treatment1 from a mean baseline body weight of 92.7 kg, people treated with amycretin achieved an estimated body weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22.0% on 20mg (36 weeks). People treated with placebo experienced an estimated 1.9%, 2.3% and 2.0% body weight gain, respectively."

P1/2 data • Metabolic Disorders • Obesity

A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Renal Disease • Type 2 Diabetes Mellitus

A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin (clinicaltrials.gov) - P2 | N=125 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Novo Nordisk A/S | Phase classification: P1 ➔ P2 | N=84 ➔ 120

Enrollment change • Phase classification • Genetic Disorders • Obesity

A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Novo Nordisk A/S | Phase classification: P1/2 ➔ P1

Phase classification • Genetic Disorders • Obesity