Amgen updates Phase 1 data for weight loss therapy
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Announcing new clinical data from a small Phase 1 trial, Amgen (NASDAQ:AMGN) said Thursday that its experimental weight loss agent AMG 133 caused up to 14.5% reduction in body weight in people with obesity and without diabetes.
The double-blind trial was the first-in-human study for the candidate, and it involved 133 healthy people with a Body Mass Index of â¥30.0 kg/m2 and â¤40.0 kg/m2.
The trial subjects were randomized to receive AMG 133 or placebo subcutaneously either in single ascending dose (SAD) or multiple ascending dose (MAD) cohorts.
According to newly announced data, the mean percent changes of body weight (BW) in MAD cohorts ranged from -7.2% at the lowest dose (140mg Q4W) to -14.5% at the highest dose (420mg Q4W) by day 85.
On the safety front, the company said that most treatment-emergent adverse events were related to the gastrointestinal system, and a majority of events were transient and mild. Additional data on the duration of effects will be shared at a medical event on Saturday.
Amgen (AMGN) plans to start a Phase 2 dose-ranging study for the candidate in early 2023. According to Morgan Stanley, rivals Novo Nordisk (NVO) (OTCPK:NONOF) and Eli Lilly (LLY) are set to dominate a multibillion-dollar market for weight loss therapies.