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New approval for tirzepatide, phase 3 wins for avexitide and retatrutide, and a GLP-1 telehealth safety gap in August's biggest endocrinology stories.
August brought a wave of movement across diabetes care, from a new cardiovascular indication for one of the field’s top-selling therapies, tirzepatide, to the first device capable of tracking ketones and glucose together. On the trial-data side, avexitide displayed strong phase 3 results in a condition with no approved therapies (post-bariatric hypoglycemia), and this month’s Diabetes Dialogue podcast explored topline retatrutide data alongside a sobering look at online GLP-1 prescribing practices.
Below is a roundup of 4 of the month's biggest endocrinology stories. The podcast episode covered here is one of 6 Diabetes Dialogue episodes posted in August.
The US Food & Drug Administration (FDA) has approved tirzepatide (Mounjaro) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk, based on results from the SURPASS-CVOT trial. The phase 3, event-driven trial enrolled > 13,000 participants and compared tirzepatide against dulaglutide (Trulicity) rather than placebo. This marked the first head-to-head cardiovascular outcomes comparison between 2 incretin therapies.
Over a median follow-up of about 4 years, tirzepatide met its non-inferiority objective for MACE-3, showing an 8% lower event rate than dulaglutide, though superiority was not established. The safety profile remained consistent with tirzepatide's existing label, with no new signals identified.
The FDA has granted De Novo marketing authorization to Abbott's Libre Duo 10 Day, the first continuous sensor worldwide to track both glucose and ketone levels in a single wearable. Authorized for patients aged ≥ 2 years with diabetes, the device measures both analytes in interstitial fluid every minute across a 10-day wear period, sending real-time readings to a smartphone and issuing alerts when ketone levels cross a risk threshold. The authorization was based on 6 clinical studies enrolling more than 600 participants and followed a Breakthrough Device designation. By pairing continuous ketone surveillance with glucose data for the first time, the device aims to help flag rising ketones before diabetic ketoacidosis develops.
Amylyx Pharmaceuticals reported positive topline results from the phase 3 LUCIDITY trial of avexitide, an investigational GLP-1 receptor antagonist, in adults with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass. The 78-participant trial met its FDA-agreed primary endpoint, with avexitide reducing composite Level 2 and Level 3 hypoglycemic events by 55% versus placebo (P =.000003) over 16 weeks, and it met all secondary endpoints as well. Amylyx plans to submit a new drug application (NDA) by the end of 2026, with a potential launch in 2027 if approved.
On this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, break down topline phase 3 results for retatrutide, a GLP-1/GIP/glucagon triple receptor agonist. In TRIUMPH-2, the 12 mg dose produced roughly 21% weight loss and an A1C reduction of 1.4-1.6 percentage points from a 7.7% baseline. In TRIUMPH-3, the 12 mg dose delivered 23% weight loss versus 3% with placebo, alongside improvements in triglycerides, non-HDL cholesterol, and systolic blood pressure. The hosts also discuss a JAMA secret-shopper study finding that 92% of telehealth sites tested prescribed a requested GLP-1 medication, often with minimal verification, raising questions about oversight in online prescribing.
Other episodes of Diabetes Dialogue posted in August: