Amgen Submits IND Application in China for First-in-Class Monthly Obesity Therapy AMG 133

On September 6, Amgen's AMG133 was submitted for clinical trial in China, for the treatment of overweight or obesity.

AMG133 is a first-in-class bispecific antibody-peptide conjugate for the treatment of obesity, administered once every 4 weeks via subcutaneous injection. This drug simultaneously inhibits the glucose-dependent insulinotropic polypeptide receptor (GIPR, also known as gastric inhibitory polypeptide receptor) and activates the glucagon-like peptide-1 receptor (GLP-1R). GLP-1 and GIP are two natural incretins that have been shown to reduce food intake, regulate metabolism, and aid in weight loss and blood sugar reduction.

Previously, Amgen announced the Phase I trial results of AMG 133 for the treatment of obesity: in the 420mg group, patients experienced continuous weight loss over 210 days, achieving an 11.2% reduction in body weight; in the 280mg group, the weight loss effect reached approximately 10% by day 85 and remained largely unchanged until the end of the observation period.

AMG133 demonstrated good safety, with no significant safety issues identified in the study. Most adverse reactions were mild and transient, primarily related to the gastrointestinal tract, with nausea and vomiting being the most common. The majority of events resolved within 48 hours.

Earlier this year, Amgen initiated the Phase II clinical trial (NCT05669599) for AMG133. This study plans to enroll 133 participants to evaluate the dose-response of three selected doses of AMG 133 compared to placebo in patients who are overweight or obese without diabetes (Cohort A) and those who are overweight or obese with type 2 diabetes (Cohort B), assessing changes in body weight from baseline during a 52-week induction and maintenance treatment period.

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