Pivots, Patents, and Peptide Conjugates
Week Of February 7 – February 13, 2026
After shelving its own oral GLP-1 candidate (danuglipron) over safety concerns, Pfizer moved from acquiring obesity biotech Metsera to registering a Phase 3 trial for its new injectable, PF-08653944 (formerly MET097), in record time — betting on “biased agonism” and monthly dosing to differentiate from competitors. I dig into the speed of that pivot in this week’s Trial Spotlight section. On the mechanism side, Amgen’s MariTide — an antibody-peptide conjugate (APC) that takes the opposite approach to GIP from most competitors — is ramping up its massive cardiovascular outcomes trials, which gave me a good reason to explain how the APC platform works in the Mechanism Explained section. On the legal front, Novo Nordisk escalated its compounding battle, suing Hims & Hers for patent infringement.
🔥 THIS WEEK’S KEY DEVELOPMENTS
Viking to Advance Oral Obesity Drug VK2735 into Phase 3
Viking Therapeutics plans to advance its oral GLP-1/GIP agonist, VK2735, into Phase 3 development for obesity in 3Q26, following feedback from the FDA. The Phase 3 VANQUISH program for subcutaneous VK2735 is ongoing, with the VANQUISH-1 study having completed enrollment of over 4,500 patients and the VANQUISH-2 study expected to complete enrollment in 1Q26. Additionally, a fully enrolled maintenance dosing study for VK2735 is expected to report results in 3Q26.
Press | Trials: NCT07104383 | NCT07104500 | NCT06068946 | Mechanism: dual agonist of the GLP-1 and GIP receptors
Novo Nordisk sues Hims & Hers over knock-off Wegovy and Ozempic.
Novo Nordisk announced it has filed a lawsuit against telehealth company Hims & Hers for infringing US Patent 8,129,343 with its compounded semaglutide products, which Novo Nordisk calls unapproved knock-off versions of Wegovy® and Ozempic®. The company is asking the court to permanently ban Hims from selling these products and is seeking to recover damages. Novo Nordisk stated its testing found impurities of up to 86% in compounded injectable semaglutide drugs and as high as 75% in compounded oral versions.
Press | Mechanism: GLP-1 receptor agonist
💡 TRIAL SPOTLIGHT
Educational spotlight selected by editors
From Acquisition to Phase 3 in Record Time: Pfizer’s PF-08653944 Enters Late-Stage Development
Following a rapid strategic pivot after its late-2025 acquisition of Metsera — and the earlier discontinuation of its own oral GLP-1 candidate, danuglipron, due to liver safety signals — Pfizer has aggressively advanced PF-08653944 (formerly MET097) into pivotal development by simultaneously registering a Phase 3 efficacy trial in patients with Type 2 diabetes and a Phase 1 pharmacokinetic study. The drug is distinct as a “fully-biased” GLP-1 receptor agonist, engineered to preferentially activate cAMP signaling while limiting beta-arrestin recruitment, a mechanism hypothesized to maintain weight-loss potency while minimizing gastrointestinal side effects. This biochemical profile also supports an ultra-long-acting duration, allowing Pfizer to target a competitive monthly dosing schedule that differentiates the therapy from current weekly standards. The immediate transition from a Phase 2b readout to Phase 3 registration highlights a parallel processing strategy, where formulation optimization and efficacy validation occur concurrently to accelerate the drug’s timeline in a crowded obesity market.
🔬 MECHANISM EXPLAINED
Understanding the science behind the therapeutics
Antibody-Peptide Conjugates: How MariTide Achieves Monthly Dosing and a Contrarian GIP Bet (Example drug: Maridebart cafraglutide / AMG 133)
Amgen’s maridebart cafraglutide (MariTide) showcases the power of the antibody-peptide conjugate (APC) platform to create a differentiated therapeutic for obesity. This modality fuses a GLP-1 receptor agonist peptide to a monoclonal antibody, where the antibody serves two critical functions: it dramatically extends the drug’s half-life to enable monthly or less frequent dosing, and it is engineered to act as a GIP receptor antagonist. This dual mechanism of GLP-1 agonism for appetite suppression and GIP antagonism to potentially reduce fat storage positions MariTide uniquely in a competitive landscape dominated by dual GLP-1/GIP agonists like tirzepatide. The robust Phase 2 weight loss data for MariTide suggests that GIP antagonism is a clinically viable strategy, fueling a key scientific debate over the optimal way to modulate the GIP pathway in metabolic disease. With Amgen adding over 80 new trial sites to the MARITIME-CV and MARITIME-HF Phase 3 programs this week alone, the aggressive clinical expansion signals high confidence in this unique “agonist-antagonist” mechanism and its potential to offer a major advantage in patient convenience and long-term adherence.
🆕 NEWLY REGISTERED TRIALS (6 in last week)
Semaglutide Phase 4 trial evaluating its effect on clinical outcomes and metabolic inflammation in patients with psoriasis (Hospital Universitario Dr. Jose E. Gonzalez, n=62)
[New Indications]
Trials: NCT07401992 (SEMAPSO) | Mechanism: GLP-1 receptor agonist
PF-08653944 Phase 1 pharmacokinetics study in adults with overweight or obesity (Pfizer, n=54)
[Weight Loss/Efficacy]
Trials: NCT07400679 | Mechanism: GLP-1 receptor agonist
Aleniglipron Phase 2 evaluating the oral GLP-1 receptor agonist in adults with Type 2 Diabetes (Structure Therapeutics, n=50)
[Weight Loss/Efficacy]
Trials: NCT07400588 (GSBR-1290) | Mechanism: GLP-1 receptor agonist
PF-08653944 Phase 3 investigating the study drug in adults with obesity or overweight and Type 2 Diabetes (Pfizer, n=999)
[Weight Loss/Efficacy]
Trials: NCT07400653 | Mechanism: GLP-1 receptor agonist
AMAZE 8 Phase 3 trial comparing NNC0487-0111 to semaglutide for weight loss in adults with excess weight and Type 2 Diabetes (Novo Nordisk A/S, n=1000)
[Weight Loss/Efficacy]
Trials: NCT07400107 (AMAZE 8) | Mechanism: GLP-1 + amylin combination
UBT251 Phase 2 dose-ranging study for adults living with overweight or obesity (Novo Nordisk A/S, n=333)
[Weight Loss/Efficacy]
Trials: NCT07395687 | Mechanism: Triple GLP-1/GIP/glucagon agonist
This newsletter compiles publicly available information from company press releases and ClinicalTrials.gov. Not investment advice.
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