Obesity Updates: WHO EML GLP-1s, Orforglipron P3, Korea MOU and More
Your rapid roundup of Obesity — spanning China, Korea, the U.S., and global access. From supply-chain shifts to digital endpoints and policy updates, get the signal without the noise.
In Today’s Newsletter
🧪 Chinese GLP-1 supply pivots toward generics [1] [03 Sep 2025]
https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-companies-turn-generics-shipments-behind-us-weight-loss-craze-fade-2025-09-03/
Context: Reuters cites sources and U.S. FDA shipping/public records on semaglutide/tirzepatide ingredient flows; mentions Sinopep-Allsino and Hybio.
Key point: As U.S. regulators restrict compounded copies, shipments of raw GLP-1 ingredients to the U.S. have slowed; Chinese firms are racing to make approved generics as patents expire (geos vary).
Implication: Introduces competition that may affect pricing and formulary access.
📱 Ametris launches DECODE Obesity with pharma partners [2] [03 Sep 2025]
https://www.mobihealthnews.com/news/ametris-expands-obesity-drug-development-project-pharma-companies
Context: Ametris (formerly ActiGraph) adds a second DECODE working group; aligns with FDA DHT guidance for remote data acquisition.
Key point: Collaboration with Eli Lilly, Roche, and Novo Nordisk aims to validate remote endpoints for physical activity, function, and sleep in obesity trials.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
💸 Congruence raises $32M for MC4R-deficient obesity program [3] [04 Sep 2025]
https://www.prnewswire.com/news-releases/congruence-therapeutics-announces-closing-of-32m-financing-to-advance-first-in-class-genetic-obesity-candidate-drug-cgx-926-through-phase-1b-proof-of-concept-clinical-trial-302545974.html
Context: Financing from existing investors to advance CGX-926 and other programs discovered via the Revenir™ computational engine.
Key point: Funds will support Phase 1 (healthy volunteers) with a Phase 1b efficacy cohort in MC4R-deficient patients (start planned early 2026).
Implication: Signals pipeline investment and modality expansion.
🇰🇷 VIVUS showcases Qsymia® data at ICOMES 2025 [4] [Korea • 05 Sep 2025]
https://www.biospace.com/press-releases/vivus-showcases-leadership-in-obesity-management-at-the-2025-international-congress-on-obesity-and-metabolic-syndrome-icomes
Context: ICOMES (Seoul; Sep 4–6). QUEEN’s Phase 4 RCT in Korean adults showed −8.3% vs −2.3% weight loss with PHEN/TPM CR vs placebo; additional metabolic improvements reported.
Key point: VIVUS highlights 13 years of Qsymia® use and presents new regional RCT data supporting efficacy and body-composition benefits.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Lilly starts Phase 3 plan for orforglipron in OA + obesity [5] [05 Sep 2025]
https://www.theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/34630697/eli-lillys-new-phase-3-study-a-potential-game-changer-for-obesity-and-osteoarthritis/
Context: Interventional, randomized, parallel, single-blind design; participants with obesity/overweight and knee osteoarthritis.
Key point: New Phase 3 will test once-daily oral orforglipron; not yet recruiting with a start date set for 02 Sep 2025 (primary/overall completion not specified).
Implication: May influence prescriber choice and payer reviews pending full data.
🌍 WHO adds GLP-1s to Essential Medicines List (EML) [6] [Global • 05 Sep 2025]
https://www.businessoffashion.com/news/beauty/who-adds-ozempic-and-mounjaro-to-essential-medicines-list/
Context: EML update includes Ozempic (semaglutide), Mounjaro (tirzepatide), Trulicity, Victoza; focus is diabetes with cardio-renal risk and obesity as comorbidity.
Key point: WHO encourages broader access and generic competition; does not endorse GLP-1s for obesity alone on the EML.
Implication: Introduces competition that may affect pricing and formulary access.
🤝 Novo Nordisk Korea × Kakao Healthcare MOU [7] [Korea • 05 Sep 2025]
https://www.mk.co.kr/en/it/11409970
Context: Second collaboration (post-2023) expands from diabetes to obesity; integration with Kakao Healthcare’s “pasta” app and Novo’s patient support tools.
Key point: Partnership targets patient-specific digital support and solutions to enhance long-term weight and health management in Korea.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.
Why it matters
GLP-1 gray-market contraction and a push to approved generics could reshape global supply, pricing, and enforcement dynamics.
Remote, validated digital endpoints may become core to obesity trials and labeling, aligning with FDA DHT guidance.
Pipeline diversification spans oral small molecules (orforglipron) and precision genetics (MC4R-d), broadening treatment options.
WHO EML inclusion for diabetes signals momentum for access, while obesity-only use remains evidence-dependent.
Regional digital health tie-ups (Korea) suggest playbooks for integrated patient support and adherence.
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FAQ
What did Reuters report about Chinese GLP-1 ingredient suppliers?
Reuters says U.S. enforcement slowed raw semaglutide/tirzepatide shipments used by compounders; some Chinese firms (e.g., Sinopep-Allsino, Hybio) are pivoting to approved generics as patents expire [1].
What is Ametris’ DECODE Obesity aiming to deliver, and who’s involved?
Ametris, with Eli Lilly, Roche, and Novo Nordisk, is working on fit-for-purpose remote endpoints (activity, function, sleep) aligned to FDA DHT guidance for clinical programs in obesity [2].
What is CGX-926 and what will the $32M fund?
CGX-926 is a small-molecule corrector for MC4R-deficient genetic obesity. Financing supports Phase 1 (HV) and a Phase 1b PoC cohort, plus advancement of GBA1 Parkinson’s and A1AT programs [3].
What data did VIVUS highlight for Qsymia®?
At ICOMES, VIVUS spotlighted the QUEEN’s Phase 4 RCT in Korean adults: greater weight loss with PHEN/TPM CR vs placebo (−8.3% vs −2.3%) and improvements in body fat and glucose metabolism [4].
What is Lilly testing in its new Phase 3?
A single-blind, randomized trial of oral orforglipron once daily in people with obesity/overweight and knee osteoarthritis; start set for 02 Sep 2025; recruiting not yet open per the update [5].
What exactly did WHO add to the EML?
GLP-1s including Ozempic, Mounjaro, Trulicity, and Victoza—primarily for diabetes with cardiovascular/kidney risk and obesity as a comorbidity; not as standalone obesity therapy on the EML [6].
Entities / Keywords
Semaglutide (Ozempic, Wegovy); Tirzepatide (Mounjaro, Zepbound); Orforglipron (Eli Lilly; oral GLP-1); Qsymia (phentermine/topiramate; PHEN/TPM CR); Ametris (ActiGraph); DECODE Obesity; Congruence Therapeutics; CGX-926; MC4R-deficient obesity; WHO Essential Medicines List; Compounding pharmacies; Sinopep-Allsino; Hybio; Kakao Healthcare; Novo Nordisk Korea; Digital Health Technologies (FDA DHT).
References
Reuters — Chinese companies turn to generics as shipments fade: https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-companies-turn-generics-shipments-behind-us-weight-loss-craze-fade-2025-09-03/
MobiHealthNews — Ametris expands DECODE Obesity: https://www.mobihealthnews.com/news/ametris-expands-obesity-drug-development-project-pharma-companies
PR Newswire — Congruence Therapeutics $32M financing: https://www.prnewswire.com/news-releases/congruence-therapeutics-announces-closing-of-32m-financing-to-advance-first-in-class-genetic-obesity-candidate-drug-cgx-926-through-phase-1b-proof-of-concept-clinical-trial-302545974.html
BioSpace — VIVUS at ICOMES 2025: https://www.biospace.com/press-releases/vivus-showcases-leadership-in-obesity-management-at-the-2025-international-congress-on-obesity-and-metabolic-syndrome-icomes
The Globe and Mail (press release) — Lilly orforglipron Phase 3 OA study: https://www.theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/34630697/eli-lillys-new-phase-3-study-a-potential-game-changer-for-obesity-and-osteoarthritis/
Business of Fashion — WHO adds GLP-1s to EML: https://www.businessoffashion.com/news/beauty/who-adds-ozempic-and-mounjaro-to-essential-medicines-list/
MK (Korea) — Novo Nordisk Korea × Kakao Healthcare MOU: https://www.mk.co.kr/en/it/11409970