7 Endocrinology Headlines You Missed in September 2025

From advances in type 2 diabetes (T2D) care and cholesterol management to economic investigations and new technologies, endocrinology has seen a surge of developments throughout September 2025.

The US Food and Drug Administration (FDA)’s approval of paltusotine has opened up an oral pathway for the treatment of acromegaly. The SURPASS-PEDS and ACHIEVE-3 trials highlighted the efficacy of both existing and experimental T2D treatments. And a study from the Karolinska Institute in Scotland has highlighted the increased risk of T2D in patients with a history of heavy smoking.

Given the sheer amount of important news, the editorial team at HCPLive has collected some of the most impactful headlines from September 2025 below.

FDA News

FDA Grants De Novo Classification to Needle-Free Glucose Monitor

The Biolinq Shine is the first needle-free glucose biosensor approved for non-insulin-dependent type 2 diabetes and stands to radically change the treatment paradigm for diabetes at large. The device also collects real-time glucose feedback, displaying it via a colored LED display. A De Novo classification opens the way for parent company Biolinq Incorporated to scale a new generation of wearable sensors.

FDA Approves Paltusotine (Palsonify) As First Once-Daily, Oral Acromegaly Treatment

On September 25, the FDA approved the first once-daily oral treatment for acromegaly in adults who had inadequate responses to, or were unable to have, surgery. Patient-reported symptoms of acromegaly saw a sharp decrease in both the PATHFNDR-1 and 2 trials, which laid the groundwork for this approval. According to parent company Crinetics, paltusotine is expected to be available in the US in early October.

Trial Results

CORALreef Lipids: Enlicitide Achieves All Endpoints in Hypercholesterolemia Trial

Enlicitide, an oral PCSK9 inhibitor for hypercholesterolemia in adults with increased risk for atherosclerotic cardiovascular disease (ASCVD), showed a significant reduction in low-density lipoprotein cholesterol (LDL-C) versus placebo. Investigators also noted reductions in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a). The CORALreef clinical trial program, of which CORALreef Lipids is a part, is ongoing and actively investigating the safety and efficacy of enlicitide.

SURPASS-PEDS: Tirzepatide Achieves Superiority to Placebo in Adolescent T2D

Tirzepatide treatment led to superior improvements in both A1C and body mass index (BMI) versus placebo in adolescents with T2D, according to a presentation by Eli Lilly at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025. First approved in 2022 as an injection for use as an adjunct to diet and exercise for improving glycemic control in adults, tirzepatide is now in investigation for children and adolescents ages 10-18 with T2D inadequately controlled with metformin, basal insulin, or both.

ACHIEVE-3: Orforglipron Superior to Semaglutide for Type 2 Diabetes in Phase 3 Trial

The investigational once-daily small molecule oral GLP-1 receptor agonist has proven its superiority in treating T2D inadequately controlled with metformin. Orforglipron lowered A1C by an average of 1.9% at a 12 mg dose and 2.2% in a 36 mg dose, compared to 1.1% and 1.4% with semaglutide 7 mg and 14 mg, respectively. The ACHIEVE global clinical development program is still ongoing; parent company Eli Lilly expects results by the end of 2025 and into 2026.

Important Studies

Smoking Increases Risk of All Type 2 Diabetes Subtypes

Based on research from the Karolinska Institute, individuals with a history of smoking have a substantially higher risk of T2D across all possible subtypes versus those who have never smoked. Heavy smokers – defined in the study as 20 cigarettes a day for 15 years – were 2.35 times more likely to develop all 4 subtypes; this was exacerbated in patients with reduced insulin secretion or a predisposition to T2D.

Diabetes Dialogue: Results of ATTAIN-1 and STEP UP Phase 3 Trials

In this episode of Diabetes Dialogue, cohosts Natalie Bellini, DNP, and Diana Isaacs, PharmD, discuss 2 more revolutionary trials in endocrinology: ATTAIN-1, an investigation of orforglipron in patients with obesity or overweight and a weight-related medical problem without diabetes, and STEP-UP, a trial of semaglutide 7.2 mg in adults with obesity. Both trials were successful and opened pathways to new, alternative, and potentially revolutionary treatment strategies for obesity.