Obesity Today—October 21, 2025

LucidQuest

3 weeks ago

Stay updated with this week’s obesity news, covering key developments and advancements across top biopharma companies.

In this Newsletter

💊 Orforglipron Phase 3 readouts in T2D [1] [16 Oct 2025]

https://www.clinicaltrialsarena.com/news/eli-lillys-oral-glp-1ra-gains-fourth-phase-iii-type-2-diabetes-win/
Context: ACHIEVE-2 (NCT06192108) showed superiority vs dapagliflozin; ACHIEVE-5 (NCT06109311) showed dose-range efficacy vs placebo; article cites A1C changes.
Key point: Lilly’s oral GLP-1RA orforglipron met primary and all key secondary endpoints in ACHIEVE-2 vs dapagliflozin and in ACHIEVE-5 vs placebo, with reported A1C reductions across doses.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 ASC30 once-monthly depot, U.S. Phase IIa fully enrolled [2] [US; 19 Oct 2025]

https://www.prnewswire.com/news-releases/ascletis-completes-enrollment-in-us-phase-iia-study-for-its-once-monthly-subcutaneous-depot-treatment-formulation-of-small-molecule-glp-1r-agonist-asc30-for-obesity-302587485.html
Context: Randomized, double-blind, placebo-controlled, multi-center; small-molecule GLP-1R agonist with Phase Ib half-life observations supporting monthly dosing.
Key point: Ascletis completed enrollment (n=65) in a 12-week U.S. Phase IIa of ASC30 depot for obesity; topline expected Q1 2026 (endpoint not specified).
Implication: May influence prescriber choice and payer reviews pending full data.

💰 Kailera raises $600M to advance KAI-9531 to Phase 3 [3] [14 Oct 2025]

https://www.kailera.com/press-release/kailera-therapeutics-announces-600-million-series-b-financing-to-further-advance-pipeline-of-next-generation-therapies-for-the-treatment-of-obesity/
Context: End-of-Phase 2 FDA meetings completed; Phase 3 to include obesity with and without T2D, plus a high-BMI cohort.
Key point: Kailera secured $600M Series B led by Bain Capital PE to fund a global Phase 3 program for injectable dual GLP-1/GIP KAI-9531 and pipeline work.
Implication: Signals pipeline investment and modality expansion.

🇿🇦 Aspen: SA approval and Mounjaro KwikPen launch coverage [4] [South Africa; 14 Oct 2025]

https://www.moneyweb.co.za/news/companies-and-deals/aspen-pharmacare-hopes-weight-loss-product-will-fatten-profits/
Context: Article frames potential market impact given high national obesity rates and Aspen’s financial backdrop.
Key point: Moneyweb reports Aspen received SAHPRA approval for a weight-management product and is launching Lilly’s Mounjaro KwikPen in South Africa.
Implication: Access programs may expand screening, initiation, and follow-up at scale.

🇰🇷 Korea to tighten oversight of Wegovy misuse [5] [South Korea; 15 Oct 2025]

https://biz.chosun.com/en/en-science/2025/10/15/RG5ZYPXLAVE2LNKV5JBEIMSM5Q/
Context: Parliamentary audit cited off-label patterns and safety concerns; measures to align practice with MFDS standards planned.
Key point: Health minister Jung Eun-kyeong pledged stricter management of anti-obesity drug prescribing amid reports of cosmetic-use misuse, including minors and pregnant women.
Implication: Could inform practice and payer discussions; interpretation depends on policy design and implementation.

🤝 Wegovy co-promotion in Japan, Nov start [6] [Japan; 14 Oct 2025]

https://www.sumitomo-pharma.com/news/20251014-2.html Context: Builds on joint Ozempic co-promotion since Jul 2025; Wegovy marketed in Japan since 22 Feb 2024.
Key point: Sumitomo Pharma and Novo Nordisk Pharma agreed to co-promote Wegovy in Japan, starting Nov 2025; Novo retains MAH and supply.
Implication: Partnerships/BD signals pipeline investment and modality expansion.

📈 New definition could push U.S. obesity prevalence to ~70% [7] [US; 16 Oct 2025]

https://www.news-medical.net/news/20251016/Mass-General-Brigham-study-shows-US-obesity-could-jump-from-4025-to-7025.aspx
Context: Adds anthropometric measures and clinical impairment tiers; newly classified group showed elevated cardio-metabolic risk.
Key point: Mass General Brigham analysis applying a Lancet Commission framework found obesity prevalence 68.6% vs 42.9% under BMI alone in >300k All of Us participants.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💵 Reuters: GLP-1 makers’ shares fall on U.S. price-cut vow [8] [US; 17 Oct 2025]

https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-shares-fall-5-after-trump-vows-weight-loss-drug-price-cut-2025-10-17/
Context: Commentary framed as a negotiating lever; firms said they are in discussions; analysts noted potential pricing scenarios.
Key point: Reuters reports Novo, Lilly and peers declined after President Trump said prices for Ozempic and related GLP-1s would be lowered under “most favored nation” efforts.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Oral GLP-1 progress and dual-agonist financing point to broader modality and route diversification.
Monthly depot small-molecule approaches target adherence and supply constraints.
Market access dynamics are shifting, from SA launches to Japan co-promotion, while Korea signals tighter control.
Redefining obesity could expand eligible populations, impacting screening, treatment demand, and payer policy.
U.S. pricing signals raise uncertainty for revenue models across the GLP-1 class.

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FAQ

What did Lilly’s orforglipron show in Phase 3?

ClinicalTrialsArena reports ACHIEVE-2 beat dapagliflozin on primary and key secondary endpoints, and ACHIEVE-5 beat placebo, with stated A1C reductions across doses [1].

What is Ascletis testing with ASC30?

A once-monthly subcutaneous depot formulation of a small-molecule GLP-1R agonist in a 12-week randomized, placebo-controlled U.S. Phase IIa (n=65); topline Q1 2026, endpoints not specified in release [2].

How will Kailera use its $600M Series B?

To initiate a global Phase 3 program for KAI-9531, an injectable dual GLP-1/GIP agonist, including trials with and without T2D, and to advance its obesity pipeline [3].

What’s new for South Africa’s market?

Moneyweb says Aspen received SA approval for a weight-management product and is launching Mounjaro KwikPen, potentially expanding weekly self-administration access [4].

What changes in Japan for Wegovy?

Sumitomo and Novo Nordisk will co-promote Wegovy starting Nov 2025, with Novo retaining approval, manufacture, and supply responsibilities [6].

How might the new obesity definition affect care?

Mass General Brigham found many with normal BMI but adverse anthropometrics have higher cardio-metabolic risk, which could broaden treatment consideration, pending validation and payer alignment [7].

Entities / Keywords

Orforglipron (Eli Lilly; oral GLP-1); ACHIEVE-2; ACHIEVE-5; Dapagliflozin/Farxiga (AstraZeneca); ASC30 (Ascletis; small-molecule GLP-1R; depot); KAI-9531 (Kailera; dual GLP-1/GIP); Mounjaro/tirzepatide (Eli Lilly); SAHPRA; Wegovy/semaglutide (Novo Nordisk); Sumitomo Pharma; MFDS (Korea); All of Us (NIH); “Most favored nation” pricing.