The defining idea of 2025 was that incretin-era obesity care moved from “how much weight can we lose?” to “can we scale durable outcomes—conveniently, safely, and affordably—without sacrificing muscle, adherence, or health-system capacity?”
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The year’s storyline: Three Obesity Shifts That Repeatedly Emerged in 2025
Convenience became a core product attribute in obesity treatment.
The pipeline leaned hard into oral GLP-1s, longer-acting injectables, depot formulations, and even implants—explicitly framed as adherence and access plays, not just lifecycle management. The competitive bar moved toward “high-efficacy + simpler delivery.”
“Weight loss at any cost” gave way to body-composition thinking.
A growing share of innovation targeted muscle preservation: myostatin-pathway strategies, selective androgen receptor modulators, and multi-agent regimens designed to retain lean mass while reducing fat. The commercial implication is straightforward: durability, tolerability, and functional outcomes are becoming differentiators.
Obesity treatment hit an access and policy choke point.
2025 repeatedly highlighted reimbursement limits, the post-shortage crackdown on compounding, and rising scrutiny over misuse and affordability. Meanwhile, manufacturers and payers experimented with direct-to-patient pricing and employer platforms—signaling that distribution and benefit design are now part of the “clinical” story.
Practice-Shaping Clinical Readouts in Obesity That Defined 2025
1) The next wave beyond weekly injectables: oral GLP-1s and once-monthly formats
Orforglipron (Eli Lilly) stayed central to the 2025 “oralization” narrative. In ATTAIN 2 (type 2 diabetes), the oral nonpeptide GLP-1 receptor agonist delivered dose-dependent weight loss at seventy-two weeks (about 5.5%, 7.8%, and 10.5% for the 6 mg, 12 mg, and 36 mg doses, respectively, versus 2.2% with placebo), with gastrointestinal adverse events described as mostly mild to moderate. Lilly also signaled broad filing intentions by year-end across regions.
ASC30 (Ascletis) advanced the long-acting oral theme with U.S. development steps and later-stage signals. In a December update, a U.S. Phase II program was described as meeting a 13-week endpoint with placebo-adjusted mean weight loss up to 7.7% at the 60 mg dose, and gastrointestinal adverse events characterized as mild to moderate with no drug-related serious adverse events reported.
2) “How high can we go?”: higher-dose semaglutide and the premium-efficacy tier
Novo Nordisk’s strategy in 2025 repeatedly pointed toward higher-dose differentiation and new routes of administration. A U.S. sNDA for Wegovy 7.2 mg was filed under an expedited pathway based on STEP UP, and later updates referenced CHMP support with an average weight loss of 20.7% at 72 weeks in non-diabetes obesity.
In parallel, Novo advanced its oral semaglutide obesity push: the file described FDA acceptance of a 25 mg oral formulation filing—positioned as potentially the first oral GLP-1 medication for obesity treatment.
3) Dual and triple agonists: the “multi-pathway” arms race (with China as a launch engine)
China’s pipeline and regulatory throughput became a defining 2025 feature. Mazdutide—described as a dual GLP-1 and glucagon receptor agonist—progressed from Phase 3 publication and NDA momentum to approval and commercialization. GLORY-2 data were summarized as a mean weight reduction of 18.55% versus 3.02% with placebo at week 60, plus metabolic improvements; the 9 mg dose later advanced via supplementary filing acceptance by China’s NMPA.
Commercially, the same file framed China as an increasingly consequential obesity market with intensifying competition as patent cliffs approach and domestic entrants multiply.
4) Amylin is back: pairing, sequencing, and muscle-sparing logic
A major 2025 “second-act” story was amylin’s re-emergence—often positioned as the way to improve tolerability, preserve lean mass, and extend efficacy beyond GLP-1 monotherapy.
- Roche–Zealand Pharma (petrelintide): a $5.3 billion alliance centered around an investigational amylin analog highlighted the strategic value of muscle-sparing and satiety pathways, with a shared global commercialization model.
- AbbVie–Gubra (GUB014295): AbbVie paid $350 million for rights to a long-acting amylin analog, reinforcing how quickly amylin moved from “adjacent” to “must-have” within portfolios.
- Metsera (later acquired by Pfizer): Metsera’s amylin program MET-233i was repeatedly cited in the context of monthly dosing and combination plans, culminating in Pfizer’s acquisition and explicit milestone-linked value tied to Phase 3 initiation and approvals.
5) The muscle question becomes quantifiable: combination regimens and adjuncts
Several 2025 updates framed muscle preservation as an investable, testable endpoint rather than an abstract concern.
- Regeneron reported interim data for a triplet regimen (semaglutide + trevogrumab + garetosmab) intended to support fat loss while maintaining muscle mass, though higher discontinuation rates due to side effects were flagged.
- Skye Bioscience (nimacimab + tirzepatide) reported Phase 2 results described as exceeding thirty percent total body weight loss in combination—positioned as differentiated via CB1 biology and side-effect considerations.
- Veru (enobosarm) was described as reducing fat while preserving lean mass in Phase 2b, with FDA planning discussions for Phase 3.
- Chugai + Eli Lilly were described as evaluating a combination of orforglipron with GYM329 (a myostatin inhibitor) to address muscle loss with weight reduction therapies.
6) Ultra-high efficacy moves into late-stage: retatrutide in obesity with knee osteoarthritis
Late in the year, Lilly’s triple-agonist retatrutide was described as entering Phase 3 in obesity with knee osteoarthritis (TRIUMPH-4). The update cited up to 28.7% mean weight loss and significant WOMAC pain reduction, with an adverse-event profile consistent with incretins—an example of efficacy being paired with functional outcomes that matter to payers and employers.
Obesity Approvals, guidelines, and access decisions that moved in 2025
Global guidance: WHO steps onto the Obesity field in 2025
Two WHO signals stood out. First, the WHO issued its first global guideline for GLP-1 medicines in adult obesity in December 2025, recommending conditional use of liraglutide, semaglutide, and tirzepatide in adults (excluding pregnancy) and emphasizing combination with intensive behavioral interventions.
Second, WHO added GLP-1 medicines to the Essential Medicines List for type 2 diabetes in high-risk adults, including those with comorbidities such as obesity—supporting access logic even while not listing GLP-1s solely for obesity treatment.
United States: 2025 obesity filings, compounding and reimbursement constraints
In 2025, Multiple U.S. access pressure points were emphasized. CMS did not include anti-obesity drugs in its 2026 coverage update, which was framed as a setback for accessibility and a market-moving signal.
Separately, a federal court upheld FDA action ending shortage designation for Wegovy and Ozempic, tightening the legal footing for compounding; Lilly also pursued litigation and cease-and-desist actions against compounded tirzepatide amid claims that branded supply shortages were resolved.
On the regulatory side, Novo’s oral semaglutide and higher-dose Wegovy pathways were prominent, alongside pipeline setbacks such as a clinical hold on Amgen’s AMG 513 and Pfizer’s discontinuation of danuglipron after a potential liver injury signal.
Europe, Asia, and China: 2025 obesity approvals and fast-track dynamics
Beyond the U.S., Japan’s regulatory approval of Zepbound (tirzepatide) for chronic obesity represents a material international expansion milestone.
In China, multiple NMPA-linked actions appeared, including approvals and supplementary filings around mazdutide, and the broader positioning of obesity as a national strategic priority under “Healthy China 2030.”
In South Korea, MFDS review activity around potential misuse/abuse classification of obesity drugs was highlighted as a possible access and prescribing variable, particularly given concerns about dose-splitting, rapid escalation, and illegal distribution.
Safety and Delivery Activity in Obesity in 2025: Keeping Patients on Therapy
A blunt theme in 2025 was that efficacy alone does not translate into durable real-world benefit without adherence infrastructure.
One late-June analysis summarized persistence challenges: while 63% of patients remained on GLP-1 obesity medications after one year, only 14% persisted by year three—roughly one in twelve maintaining long-term therapy. That framing helps explain why 2025 saw so much emphasis on longer-acting delivery, affordability initiatives, and side-effect mitigation.
Safety discussions were often inseparable from discontinuation risk. Regeneron’s triplet data included higher discontinuation due to side effects. In multiple oral and injectable programs, gastrointestinal adverse events were repeatedly described as mild-to-moderate but still central to patient retention and payer scrutiny.
Market access tactics also functioned as supportive care in practice: direct-to-patient pricing (e.g., $499/month offers), savings programs, and employer benefit platforms were positioned as adherence levers as much as commercial tools.
Diagnostics stratification and measurement in Obesity 2025: improved patient matching and endpoints
Precision obesity medicine surfaced repeatedly as the field tried to move beyond BMI-only thinking.
Phenomix Sciences and Mayo Clinic were cited as advancing predictive approaches, including studies aimed at anticipating GLP-1 side effects using genetic risk scores and identifying new obesity sub-phenotypes.
At the trial-measurement layer, Ametris launched DECODE Obesity with major pharma partners to co-develop remote digital endpoints (physical activity, function, sleep), aligned with FDA digital health technologies guidance—an investor-relevant shift because endpoints can reshape clinical development cost, speed, and label narratives.
Exploratory work on microbiome patterns and candidate taxa biomarkers was also described as a step toward diagnostics and therapy stratification, though clearly early-stage.
Digital care platforms were treated as scale infrastructure: Novo’s partnerships (including China-facing digital ecosystems) and Korea-focused patient support integrations were positioned to streamline initiation, adherence, and logistics.
Obesity 2025 Catalyst Calendar (only timelines explicitly stated)
Q3–Q4 2025
- Skye Bioscience nimacimab high-concentration formulation data anticipated late Q3/early Q4 2025.
- MetaVia DA-1726 higher-dose cohort results expected late 2025.
- Eli Lilly has indicated plans to release Phase 3 orforglipron obesity data in Q3 2025, ahead of intended year-end submissions.
December 2025
- Rhythm setmelanotide Priority Review with PDUFA date December 20, 2025 (acquired hypothalamic obesity).
- WHO global guideline for GLP-1 use in adult obesity released December 2025.
Early 2026
- Congruence CGX-926 Phase 1b proof-of-concept cohort planned to start in early 2026.
- Sweden obesity-focused research initiative set to begin in 2026 (ten-year effort).
2026 and beyond
- Novo Nordisk planned regulatory approval filing for CagriSema in Q1 2026 (supply chain readiness cited), and Phase III development for amycretin scheduled to begin in 2026.
- Novo Nordisk Brazil semaglutide facility operations expected to commence by 2028.
- Dongsung Chemical GMP semaglutide capacity targeted by 2029.
Key Obesity Takeaways From 2025
Obesity’s 2025 pattern was clear: the GLP-1 era matured into a platform race defined by oral and long-acting delivery, multi-hormone and amylin-based combinations, and body-composition-aware regimens—all unfolding under intensifying policy, reimbursement, and compounding enforcement pressures. For investors and C-suite leaders, the throughline is that the winners won’t be determined by efficacy alone, but by who can deliver scalable outcomes with defensible access, manufacturability, and adherence infrastructure.
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