Latest obesity treatment advancements: Clinical trial updates and pharmaceutical developments
This week’s edition, brought to you by LucidQuest, highlights regulatory moves, clinical trial results, and emerging biotech innovations shaping the future of obesity care.
Key Highlights:
🔬 Novo Nordisk – Plans CagriSema regulatory submission in Q1 2026 after ensuring supply readiness
📊 CagriSema Phase 3 Update – New Redefine-11 trial to optimize dosing after unexpected Redefine-1 results falling short of company expectations
🚦 FDA Clinical Hold on Amgen’s AMG 513 – Ongoing discussions to resume the obesity drug trial
🏥 Eli Lilly – Drops DACRA-based obesity candidate, shifting focus to GLP-1 treatments
🔍 Biotech Innovation – Skye Biosciences, Scholar Rock, and MBX Biosciences explore next-gen obesity drugs Clinical Trial & Market Insights:
📌 CagriSema (Novo Nordisk) – Regulatory filing delayed to Q1 2026, ensuring supply chain readiness before submission.
📌 CagriSema Phase 3 Update – Redefine-1 trial results raised concerns over weight loss results. A new study, Redefine-11, will test higher doses over a longer period to optimize efficacy.
📌 FDA Clinical Hold on Amgen’s AMG 513 – No disclosed reason, but Amgen believes the issue is unrelated to the drug itself and is working toward trial resumption.
📌 Eli Lilly Shifts Obesity Focus – DACRA-based candidate removed from pipeline, with focus now on GLP-1 therapies like Mounjaro and Zepbound.
📌 Emerging Biotech Approaches – Skye Biosciences is developing nimacimab (CB1 inhibitor) to avoid neuropsychiatric effects. Scholar Rock is testing apitegromab for lean muscle preservation. MBX Biosciences is advancing MBX4291 for improved efficacy and safety.
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