Endocrinology Month in Review: January 2025

Endocrinology started the year with an explosion of key updates, providing hope with new approvals, the potential for lower-cost drugs, and notable movement in the pipeline. Last month, the US Food and Drug Administration (FDA) announced a new approval of semaglutide for chronic kidney disease (CKD), the Centers for Medicare and Medicaid Services announced new drugs for price negotiations, and multiple companies reported positive data from their obesity and rare disease pipelines.

In our January 2025 month in review, we provide a recap of the news and stories that defined this past month in endocrinology, focusing on these regulatory updates, developments to the pipeline, and new data on the use of glucagon-like peptide-1 receptor agonists (GLP-1 RA) and patient factors influencing their use. We also highlight two episodes of our flagship diabetes podcast, Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, focusing on the American Diabetes Association (ADA) 2025 Standards of Care.

Here’s what happened in January:

Pipeline Updates

FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

The FDA approved Novo Nordisk’s semaglutide (Ozempic) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease (CVD) in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). The approval was awarded based on positive results from the Phase 3b FLOW kidney outcomes trial.

In the trial, semaglutide achieved a statistically significant and superior 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to CVD, compared with placebo, when added to the standard of care.

Semaglutide 7.2 mg Displays 20.7% Weight Loss in Phase 3b STEP UP Trial

Topline data from the Phase 3b STEP UP trial demonstrated statistically significant and superior weight loss at 72 weeks with Novo Nordisk’s semaglutide 7.2 mg irrespective of treatment adherence. The randomized, double-blinded, parallel-group, placebo-controlled trial evaluated the efficacy of semaglutide 7.2 mg to semaglutide 2.4 mg (Wegovy) and placebo in more than 1400 adults with obesity and without T2D.

HHS Targets 15 Drugs for Medicare Part D Negotiations, Including Semaglutide

The US Department of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS), announced an additional 15 drugs covered under Medicare Part D for price negotiations in 2025, including semaglutide (Ozempic; Rybelsus; Wegovy). Negotiations with participating drug companies will transpire in 2025, with any negotiated prices becoming effective in 2027.

Atumelnant Reduces Key CAH Biomarkers, Hits Primary Phase 2 Endpoint

Crinetics Pharmaceuticals, Inc. announced positive topline results from the Phase 2 TouCAHn trial investigating atumelnant for the treatment of classic congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome. Atumelnant, a novel oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate, achieved rapid reductions in key CAH biomarkers, including an up to 80% reduction in mean androstenedione.

Enobosarm Protects Lean Mass in Topline Phase 2b Trial Results

Veru Pharmaceuticals announced enobosarm, a novel oral daily selective androgen receptor modulator (SARM), achieved a statistically significant reduction in the loss of lean mass in patients receiving semaglutide (Wegovy) for weight reduction. The Phase 2b QUALITY trial achieved its primary endpoint, with further positive effects on key secondary endpoints, including the change from baseline total fat mass, body composition, and physical function.

Diabetes Dialogue

Diabetes Dialogue: ADA’s 2025 Standards of Care in Diabetes Technology

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD and Natalie Bellini, DNP, explore the updated American Diabetes (ADA) 2025 Standards of Care, focusing on technology advancements in diabetes management. They highlighted new updates including the ADA's evolving guidelines championing broader access to CGM and AID systems for personalized diabetes care

Diabetes Dialogue: ADA’s 2025 Standards of Care in Diabetes Therapeutics

Hosts further explore the latest therapeutic advancements in diabetes management highlighted by the ADA, focusing on their real-world impact on patient health. They discussed significant changes to treatment algorithms and new guidance designed to enhance outcomes for people with diabetes and related conditions, including the expanded flexibility of GLP-1 RAs for those with T2D and CKD.

Latest Research

Genetic Determinants of LDL-C Inversely Linked to Type 2 Diabetes Risk

Genetic predispositions affecting low-density lipoprotein cholesterol (LDL-C) levels, including monogenic and polygenic mechanisms, were inversely linked to the risk of T2D in new analyses. Evaluating a population of ≥361,000 adults in the UK Biobank, across a follow-up of 14 years, investigators found the index of T2D risk robustly associated with the level of genetic disturbances in LDL-C levels.

Patient Factors Influence Semaglutide Initiation After Obesity Diagnosis

Sociodemographic, healthcare, and clinical factors were linked to the initiation of semaglutide in a population with obesity without T2D. Among more than 97,000 commercially insured adults in a recent cohort study, approximately 2.0% began semaglutide treatment within 6 months of an obesity diagnosis, with sex (female) insurance plan (point-of-service), and medication (antidepressants) representing relevant factors for initiation.

Thyroid Cancer Diagnoses Rise in First Year of GLP-1 RA Use

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy raised the risk of new thyroid cancer diagnosis within the first year of initiation, compared with other diabetic medications, although these increases faltered in later follow-up periods. Analysis of nearly 352,000 adults with T2D at risk for CVD found a low absolute risk of thyroid cancer among GLP-1 RA users, linking the first-year increase in diagnoses to increased screening rates.

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