Drugs

Amycretin Sees 14.5% Weight Loss in Phase 2 Diabetes Trial

Novo Nordisk is reporting favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing significant reductions in both weight and blood sugar among adults with Type 2 diabetes inadequately controlled on standard therapies. The study marks the first time amycretin has been tested in a Type 2 diabetes population, according to the company. The once-weekly injectable and once-daily oral versions of the drug — a single molecule designed to activate both GLP-1 and amylin receptors — delivered dose-dependent improvements in HbA1c and body weight over 36 weeks, it says.

In the 448-person trial, participants had baseline HbA1c levels near 8% and were taking metformin, with about 40% also on an SGLT2 inhibitor, the company says. The highest doses of injectable amycretin reduced HbA1c levels by up to 1.8 percentage points, with 89.1% of participants reaching the American Diabetes Association’s target of less than 7%. Among oral users, reductions reached 1.5 percentage points, with 77.6% achieving target levels. All amycretin arms met the study’s primary endpoint of statistically significant HbA1c improvement versus placebo, it adds.

Weight loss was similarly robust, according to the company. Participants receiving the highest subcutaneous dose lost up to 14.5% of baseline body weight, compared with 2.6% on placebo. The oral formulation delivered weight loss of up to 10.1%, versus 2.5% on placebo, it notes, adding that both formulations were generally well tolerated. Side effects were mostly gastrointestinal and mild to moderate, aligning with other GLP-1–based and amylin-based therapies.

Novo Nordisk says it will begin Phase 3 trials across multiple indications in 2026.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome