Obesity Today—December 2, 2025

This week’s obesity update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.

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🧪 Gan & Lee starts once-monthly GLP-1 RA Phase 3 (bofanglutide) [1] [China • 28 Nov 2025]

https://www.clinicaltrialsarena.com/news/gan-lee-clinical-trial/

Context: GRADUAL program includes three Phase 3 studies in >1,000 participants in China; GRADUAL-3 tests monthly SC dosing over 24 weeks for weight-loss maintenance.

Key point: Primary endpoints are percent change and absolute change in body weight at week 24; prior GRADUAL-1/-2 evaluate 52-week efficacy and compare to Wegovy (n not stated here).

Implication: Signals pipeline investment and modality expansion.

🔬 Amycretin hits Phase 2 goals in T2D with weight loss and HbA1c drops [2] [25 Nov 2025]

https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916463

Context: 448 adults with T2D on metformin ± SGLT2i; six weekly SC doses and three daily oral doses to 36 weeks.

Key point: Dose-dependent HbA1c reductions up to −1.8% (SC) and −1.5% (oral) vs placebo, plus weight loss up to −14.5% (SC) and −10.1% (oral); GI AEs mostly mild to moderate.

Implication: May influence prescriber choice and payer reviews pending full data.

⚖️ Mazdutide 9 mg filing accepted by China’s NMPA for long-term weight management [3] [China • 25 Nov 2025]

https://www.prnewswire.com/news-releases/mazdutide-9mg-supplementary-application-accepted-for-review-by-chinas-nmpa-potentially-offering-a-novel-drug-option-for-moderate-to-severe-obese-population-302625421.html

Context: Supplementary application supported by Phase 3 GLORY-2 in Chinese adults with moderate-to-severe obesity.

Key point: GLORY-2 met primary and key secondary endpoints; at week 60 mean weight change −18.55% vs −3.02% placebo, with added metabolic improvements; safety favorable per release.

Implication: Introduces competition that may affect pricing and formulary access.

📈 Novo Nordisk files FDA sNDA for Wegovy 7.2 mg dose [4] [US • 26 Nov 2025]

https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-a-higher-dose-of-wegovy-injection-7-2-mg-302626162.html

Context: STEP UP Phase 3, 72 weeks, 1,407 adults with obesity without diabetes, compares 7.2 mg vs 2.4 mg vs placebo alongside lifestyle.

Key point: Mean weight loss 20.7% (adherent estimand) with 7.2 mg vs 17.5% with 2.4 mg and 2.4% placebo; higher GI AEs with 7.2 mg; expedited review program noted.

Implication: Introduces competition that may affect pricing and formulary access.

🏭 Lilly peptide supply, Korea build-out reported with SK Pharmteco [5] [Korea • 01 Dec 2025]

https://biz.chosun.com/en/en-science/2025/11/28/PABBEIAAAJFGNEWEQ2UJXBUC4Y/

Context: SK Pharmteco constructing large-scale peptide API facilities in Sejong, with cGMP and QC; plant completion targeted mid-2026 per report.

Key point: Media report says Lilly supply under review at Plant 4 and Peptron is a candidate for finished-product manufacturing; no official SK statement cited.

Implication: Signals pipeline investment and modality expansion.

Why it matters

GLP-1 and combinatorial incretin pipelines are expanding across modalities, doses, and dosing intervals.
China filings and trials point to rapid regional competition and potential local access pathways.
Higher semaglutide doses seek incremental efficacy that could reset payer benchmarks.
Dual GCG/GLP-1 programs may challenge surgery in severe obesity if safety and durability hold.
Manufacturing scale-up hints at sustained demand and potential supply resilience.

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FAQ

What is bofanglutide (GZR18) and what does GRADUAL-3 test? [1]

Bofanglutide is a once-monthly GLP-1 receptor agonist from Gan & Lee. GRADUAL-3 is a 24-week Phase 3 in Chinese adults with overweight or obesity focusing on weight-loss maintenance, with body-weight change at week 24 as primary endpoints [1].

How did amycretin perform in Phase 2 for T2D? [2]

In 448 adults with T2D on metformin ± SGLT2i, amycretin showed dose-dependent HbA1c reductions up to −1.8% (SC) and −1.5% (oral) and weight loss up to −14.5% (SC) and −10.1% (oral) vs placebo over 36 weeks. Safety was generally consistent with incretin and amylin-based agents, mostly GI AEs [2].

What supports Innovent’s mazdutide 9 mg NMPA submission? [3]

Phase 3 GLORY-2 in Chinese adults with moderate-to-severe obesity met primary and key secondary endpoints. The release cites −18.55% mean weight loss at week 60 vs −3.02% placebo and improvements across cardiometabolic measures, with a favorable safety profile [3].

What distinguishes Wegovy 7.2 mg from the current 2.4 mg dose? [4]

In STEP UP, 7.2 mg achieved greater mean weight loss than 2.4 mg at 72 weeks in adults without diabetes, with more GI AEs reported. The filing is under an expedited FDA review program per Novo Nordisk [4].

What is the status of Lilly’s Korea manufacturing plans? [5]

Biz Chosun reports SK Pharmteco is building peptide API capacity in Sejong, with inspections by Lilly staff and potential Peptron involvement for finished product. SK has not issued an official position per the article [5].

Entities / Keywords

Gan & Lee; bofanglutide; GZR18; GRADUAL-1/-2/-3; Novo Nordisk; amycretin; GLP-1; amylin; Innovent Biologics; mazdutide; GLORY-2; NMPA; semaglutide; Wegovy 7.2 mg; STEP UP; FDA sNDA; SK Pharmteco; SK Biotek; Peptron; Eli Lilly; peptide API; obesity; T2D.