Weight Loss Drug's New Entrant: Amgen To Compete With Novo Nordisk, Eli Lilly, As Investigational Weight Loss Drug Shows Encouraging Early Data

Amgen Inc AMGN has the data from animal and early-stage human trials of its experimental obesity drug AMG 133 (maridebart cafraglutide) published in Nature Metabolism.

The Journal confirmed the GIPR antagonist and GLP-1R agonist activities in cell-based systems and reported the ability of AMG 133 to reduce body weight and improve metabolic markers in male obese mice and cynomolgus monkeys. 

Also Read: Amgen’s Blockbuster Osteoporosis Drug Prolia Flagged With FDA Strictest Warning.

In a phase 1 study, the participants with obesity, AMG 133, had an acceptable safety and tolerability profile along with pronounced dose-dependent weight loss. 

In the multiple ascending dose cohorts, weight loss was maintained for up to 150 days after the last dose. 

The Phase 1 trial data revealed significant weight loss among the 49 obese participants. Administered in varying doses from 21 mg to 840 mg, AMG 133 demonstrated an acceptable safety profile.

The trial highlighted common treatment-related side effects, such as nausea and vomiting. An isolated case with a 140 mg dose showed elevated pancreatic enzyme levels. 

In December 2022, Amgen presented new AMG133 Phase 1 data at the World Congress of Insulin Resistance, Diabetes, and Cardiovascular Disease Hybrid Conference.

The cohorts showed mean percent changes in body weight (BW), ranging from -7.2% at the lowest dose (140mg Q4W) to -14.5% at the highest dose (420mg Q4W) by day 85. 

The highest single dose of 840 mg resulted in a −2.8% change at day 6 and −8.2% at day 92, suggesting a prolonged weight-reducing effect after a single dose of AMG 133 compared to a mean percent change of −0.5% at day 6, 0.2% at day 29 and 1.7% at day 92 in the placebo group.

“That is really a remarkable and distinguishing characteristic of this molecule,” Bloomberg noted, citing the interview of Narimon Honarpour’s senior vice president of global development at Amgen.

A Phase 2 study of maridebart cafraglutide in overweight or obese adults with or without type 2 diabetes mellitus has completed enrollment, with topline data anticipated in late 2024.

Price Action: AMGN shares are up 1.26% at $327.28 on the last check Monday.

Photo by Vidmir Rais via Pixabay