Endocrinology Video Recap—December 16, 2025

LucidQuest

11 hours ago

This biweekly endocrinology video recap covers major regulatory decisions, late-stage clinical trials, safety alerts, and technology advances shaping the evolving metabolic and endocrine care landscape.

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Week 2–8 December 2025
Week 9 December–15 December 2025

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Transcript

Welcome to the latest edition of Endocrine and Diabetes Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

Debiopharm has randomized the first patient in OXTEND-III, a global Phase 3 study of Debio 4126, a long-acting octreotide. About 120 adults with acromegaly across 75 sites in 21 countries will test whether quarterly injections can sustain IGF-1 control while cutting injections from 12 to 4 per year, aiming to ease treatment burden.

Abbott and the FDA have flagged certain FreeStyle Libre 3 and Libre 3 Plus sensor lots for falsely low readings. About 3 million sensors are implicated, with 736 adverse events and seven deaths reported outside the United States potentially linked. Affected users should stop using the sensor and request free replacements, while readers and apps are not impacted.

China’s National Healthcare Security Administration will add Mounjaro, tirzepatide, to the national reimbursement list for type 2 diabetes on January 1, 2026. Inclusion typically broadens access while lowering price per dose, in a market with very high diabetes prevalence.

Biorep Technologies reported the first successful independent human islet isolation with the PRISM system at the Scottish National Blood Transfusion Service, in collaboration with Leiden University Medical Center. This automated, closed, modular platform aims to replace aging equipment such as the COBE 2991 as it is phased out at the end of 2025, supporting reproducible research workflows.

In the INHALE-1 trial, a 26-week randomized study in youth mostly with type 1 diabetes, inhaled Technosphere insulin did not meet the prespecified noninferiority margin of 0.4% for HbA1c versus subcutaneous rapid-acting analog insulin. The adjusted difference was 0.18%, with similar CGM metrics. Inhaled insulin showed less weight gain, 1.6 kg versus 3.0 kg, higher treatment satisfaction, and a 17% rate of cough. Early discontinuation occurred in 22% of users, with hyperglycemia the most common reason.

Wellgistics is launching Brenzavvy, bexagliflozin, across a network of 6,500 independent pharmacies. The EinsteinRx platform will prompt pharmacist outreach, targeting underuse of SGLT2 inhibitors and offering a cash price alternative to branded competitors for many of the 33 million diagnosed adults with type 2 diabetes in the United States.

A meta-review in npj Digital Medicine synthesized 60 studies on AI-enhanced wearables for type 2 diabetes and prediabetes. Many systems predict glucose changes one to two hours ahead and triage data for clinicians. Key gaps remain, including explainability, external validation, benchmark datasets, workflow fit, and access.

In Europe, the EMA has extended Mounjaro’s indication to children and adolescents aged 10 years and older with type 2 diabetes, as monotherapy when metformin is not appropriate or as add-on therapy, alongside diet and physical activity.

Also in Europe, the CHMP issued a positive opinion for Wegovy 7.2 mg. In the STEP UP program, adults with obesity and without diabetes lost an average of 20.7% of body weight at 72 weeks, with one in three achieving at least 25% weight loss. Safety and tolerability were consistent with the 2.4 mg dose. A final European Commission decision is pending.

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🗓️ Explore weekly details and sources

Week 2–8 December 2025
Week 9–15 December 2025

📚 See the full Endocrinology archive on our research hub page.

Why it matters

Safety alerts on CGM sensors affect millions of users and care decisions that hinge on accurate readings.
China’s NRDL listing can reset tirzepatide’s price–volume dynamics in a high-prevalence market.
EU label shifts for tirzepatide and semaglutide shape pediatric access and dose-escalation strategies.
Quarterly octreotide could reduce treatment burden in acromegaly if biochemical control is maintained.
Reproducible islet isolation platforms are key for translational workflows as legacy devices sunset.

FAQ

What exactly is being recalled or flagged in Abbott’s Libre line?

Per FDA and Abbott, certain FreeStyle Libre 3 and 3 Plus sensor lots can give falsely low readings. Users of affected lots should stop using them and request replacements; readers and apps are not impacted [2].

When will Mounjaro be reimbursed in China and for whom?

China’s NHSA will add Mounjaro to the national reimbursement list for type 2 diabetes on 01 Jan 2026. Broader access typically comes with price concessions [3].

What pediatric use did EMA support for tirzepatide?

EMA backed extending Mounjaro to children and adolescents aged 10 years and older with type 2 diabetes, as adjunct to diet and exercise, either monotherapy or add-on [8].

How much weight loss did Wegovy 7.2 mg show and what is the status?

CHMP issued a positive opinion for semaglutide 7.2 mg, reporting ~20.7% average loss at 72 weeks in obesity without diabetes. Final EC decision is pending [9].

Did inhaled Technosphere insulin match injectables in youth?

No. In INHALE-1, TI failed the prespecified noninferiority margin for HbA1c vs rapid-acting analog over 26 weeks, though safety and satisfaction were favorable and weight gain was lower with TI [5].

What is Biorep’s PRISM milestone?

First independent human islet isolation using PRISM at SNBTS with LUMC confirmed reproducibility across labs, supporting research-use adoption as COBE 2991 phases out [4].

Entities / Keywords

Debiopharm; Debio 4126; long-acting octreotide; acromegaly. Abbott; FreeStyle Libre 3; FDA safety communication. Eli Lilly; tirzepatide; Mounjaro; NRDL China; EMA pediatric extension. Biorep Technologies; PRISM system; islet isolation; SNBTS; LUMC. Technosphere insulin; INHALE-1. Wellgistics; Brenzavvy; bexagliflozin; SGLT2. Novo Nordisk; Wegovy; semaglutide 7.2 mg; CHMP.