Analyst Views Mixed As Amgen's Weight Loss/Diabetes Drug MariTide Shows Promise But Has Dose Issues

Core Insights - Amgen Inc announced full results from Part 1 of the Phase 2 study of MariTide, a long-acting peptide-antibody conjugate administered subcutaneously [1] Efficacy Results - In the Phase 2 study, MariTide demonstrated an average weight loss of approximately 20% in individuals with obesity without Type 2 diabetes (T2D), compared to 2.6% in the placebo group, and about 17% in individuals with obesity with T2D, compared to 1.4% in the placebo group [2] - Weight loss had not plateaued by 52 weeks, indicating potential for further reduction [2] - MariTide also showed a reduction in hemoglobin A1c (HbA1c) of up to 2.2% in obese and T2D patients [3] - Improvements were noted in cardiometabolic measures, including waist circumference, blood pressure, high-sensitivity C-reactive protein (hs-CRP), and select lipid parameters [4] Safety and Tolerability - No new safety signals were identified, and tolerability was consistent with the GLP-1 class, with gastrointestinal (GI) related adverse events being the most frequently reported, mostly mild to moderate [5] Study Progression - Complete results from the Phase 1 pharmacokinetics low dose initiation study were presented, showing an overall incidence of vomiting of 24.4% for one dose group and 22.5% for another, with no discontinuations due to GI adverse events [6][7] - The Phase 3 MARITIME program has been initiated, which is a 72-week chronic weight management study evaluating safety, efficacy, and tolerability in participants with obesity or overweight, with and without T2D [8] Future Studies - Amgen plans to initiate additional Phase 3 studies for atherosclerotic cardiovascular disease, heart failure, and obstructive sleep apnea in 2025 [9] Analyst Insights - Analysts express mixed views on the treatment policy estimand weight loss data, with some believing that reducing discontinuations through additional titration could yield Phase 3 results near 20% [9] - Questions remain regarding the potential for increased GI adverse events with expanded dosing intervals beyond every four weeks [10] Stock Performance - Following the announcement, Amgen's stock rose by 1.96% to $277.78 [10]