THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN) has unveiled results from a Phase 2 study of MariTide, an investigational treatment for obesity and Type 2 diabetes, demonstrating significant weight loss without a plateau at 52 weeks. The study indicated an average weight loss of up to approximately 20% in individuals without diabetes and around 17% in those with Type 2 diabetes. Additionally, patients with diabetes experienced a reduction in hemoglobin A1C levels by up to 2.2 percentage points.
The treatment, which is administered subcutaneously either monthly or less frequently, also showed improvements in cardiometabolic parameters, such as blood pressure, triglycerides, and high-sensitivity C-reactive protein, with no significant increase in free fatty acids or association with bone mineral density changes. The most common adverse events were gastrointestinal, but these were mainly mild and transient.
Dr. Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen, expressed confidence in MariTide's profile, which includes substantial and progressive weight loss and improvements in cardiometabolic health. This has led to the initiation of "MARITIME," a Phase 3 clinical development program for the treatment of obesity and related conditions.
MariTide's Phase 2 trial enrolled 592 adults across two cohorts, one with and one without Type 2 diabetes. The ongoing Part 2 of the study is exploring the potential for further weight loss, weight maintenance with less frequent or lower dosing, and the durability of weight loss after discontinuation of MariTide.
Amgen highlighted that MariTide would be delivered in a patient-friendly autoinjector device, emphasizing convenience. The company is also advancing its obesity pipeline with both oral and injectable approaches that include incretin and non-incretin mechanisms.
Obesity is a complex biological disease that has seen a dramatic increase in prevalence globally. In the U.S., over 42.5% of adults live with obesity. Despite this, only a small percentage of eligible adults are prescribed medication for chronic weight management.
Amgen, a biotechnology pioneer, is committed to developing innovative medicines and has a broad pipeline of treatments for various diseases. The company has been recognized as one of the world's most innovative companies and a best large employer in the U.S.
This news article is based on a press release statement.
In other recent news, Amgen Inc (NASDAQ:AMGN). announced a fourth-quarter dividend of $2.25 per share, payable to stockholders of record as of November 18, 2024. The announcement reflects the company's commitment to return value to shareholders and confidence in its financial strength and future prospects. In the realm of research and development, Amgen reported positive findings from its Phase 3 MINT trial for UPLIZNA (inebilizumab-cdon), a potential treatment for adults with generalized myasthenia gravis (gMG). The trial met its primary endpoint, demonstrating a significant change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 for patients treated with UPLIZNA compared to a placebo group. Secondary endpoints also demonstrated UPLIZNA's efficacy, with meaningful changes from baseline in the Quantitative Myasthenia Gravis (QMG) score for both acetylcholine receptor autoantibody-positive (AChR+) and muscle-specific kinase autoantibody-positive (MuSK+) populations at Week 26. However, changes in QMG score were not statistically significant in the MuSK+ group. Following these promising results, Amgen intends to seek approval for UPLIZNA in the U.S. and other key markets for the treatment of gMG. These are recent developments regarding Amgen's pursuit of innovative treatment solutions for severe autoimmune diseases.
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