ACCG-2671 / Structure Therap, Schrodinger - LARVOL DELTA

First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671 (clinicaltrials.gov) - P1/2 | N=164 | Recruiting | Sponsor: Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics

First-in-human • New P1/2 trial • Genetic Disorders • Obesity

Oral Small Molecule Dual Amylin and Calcitonin Receptor Agonists (GlobeNewswire) - "(i) ACCG-2671...continues to be evaluated in an ongoing Phase 1 single ascending dose (SAD) clinical trial assessing safety, tolerability, pharmacokinetics and food effect in healthy adult participants. Initial data, along with initiation of a multiple ascending dose (MAD) clinical trial, remain on track for Q3 2026; (ii) The Company plans to initiate a Phase 1 clinical trial of its second oral small molecule dual amylin and calcitonin receptor agonist candidate, ACCG-3535, in Q4 2026, demonstrating continued leadership in the oral small molecule amylin field."

New P1 trial • P1 data • Obesity

Combination of Oral Small Molecule GLP-1 and Amylin Receptor Agonists (GlobeNewswire) - "Preclinical combination data of aleniglipron and ACCG-2671 were presented at the ADA Scientific Sessions in June 2026 demonstrating additional weight loss compared to each monotherapy in non-human primates. A combination clinical trial is expected to be initiated in Q4 2026."

New trial • Preclinical • Obesity

Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs (ADA 2026) - "Combination therapy of long-acting peptides semaglutide and cagrilintide have demonstrated enhanced efficacy over single agents for obesity treatment in clinical trials. Combination treatment with the small molecule GLP-1R agonist aleniglipron and amylin receptor agonist ACCG-2671 demonstrated further weight loss than monotreatment in obese NHPs. These findings support further development of aleniglipron and ACCG-2671 as a potential oral fixed-dose combination therapy for obesity."

Late-breaking abstract • Metabolic Disorders • Obesity

Recent and Upcoming Milestones (GlobeNewswire) - "Initial data from the ongoing Phase 1 study of oral small molecule amylin receptor agonist ACCG-2671 and Phase 1 initiation of second oral amylin compound ACCG-3535 expected in 2H 2026...The Company expects to report topline results from the ACCESS II 44-week study in Q1 2026."

New P1 trial • P1 data • P2 data • Obesity

Structure Therapeutics Announces Initiation of Phase 1 Clinical Study of Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity (GlobeNewswire) - "The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of ACCG-2671 in both healthy volunteers and individuals with obesity. The study will include single-ascending dose and multiple-ascending dose cohorts."

First-in-human • Trial status • Obesity

Oral Small Molecule Amylin Receptor Agonists for the Treatment of Obesity or Overweight with Comorbidities (GlobeNewswire) - "ACCG-2671 – Investigational new drug enabling activities for ACCG-2671 are ongoing, with the initiation of a first-in-human Phase 1 clinical study expected by year-end 2025....A second dual amylin and calcitonin receptor agonist development candidate, ACCG-3535, has been selected. ACCG-3535 is a unique chemical structure from ACCG-2671. Preclinical ACCG-3535 data were recently presented at Obesity Week 2025 demonstrating high binding affinity to human amylin and calcitonin receptors and balanced potency in human amylin and calcitonin receptor functional assays. In addition, ACCG-3535 demonstrated robust food intake suppression and significant, dose-dependent body weight reduction as a monotherapy in diet-induced obese rats."

New P1 trial • Preclinical • Obesity

A Novel, Potent Small Molecule Dual Amylin and Calcitonin Receptor Agonist for Obesity Treatment (OBESITY WEEK 2025) - " A novel small molecule, differentiated from ACCG-2671, showed sub-nanomolar binding affinity to human AMY3R (hAMY3R) and human CTR (hCTR)... Our novel small molecule DACRA showed high potency and efficacy in vitro and in vivo, with PK properties predicting once-daily oral dosing in humans. This molecule demonstrated a promising preclinical profile, reflecting our multi-generational approach to small molecule discovery and supporting the further development of the new molecule as a novel treatment for obesity."

Genetic Disorders • Obesity

Structure Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights (GlobeNewswire) - "ACCG-2671 - Investigational new drug (IND) enabling activities for ACCG-2671 are ongoing; Structure Therapeutics plans to initiate a first-in-human Phase 1 clinical study by year-end 2025. New preclinical data for ACCG-2671 was presented in a late-breaking poster session at the American Diabetes Association 85th Scientific Sessions in June 2025....In diet-induced obese rats, oral administration of ACCG-2671 resulted in significant, dose-dependent body weight reductions. Combination therapy with semaglutide (both as add-on and concurrent treatment) resulted in superior weight loss compared to monotherapy of either compound."

New P1 trial • Preclinical • Obesity

Novel Oral Small Molecule ACCG-2671—A Dual Amylin and Calcitonin Receptor Agonist Development Candidate for Obesity Therapy (ADA 2025) - "Cagrilintide, a long-acting dual amylin and calcitonin receptor agonist (DACRA) peptide, has demonstrated promising efficacy and safety profile in clinical trials, but an oral small molecule DACRA with good bioavailability and stability could provide a more convenient and accessible alternative for obesity treatment. ACCG-2671 is a novel oral small molecule DACRA that significantly reduces body weight in obese rats. Its pharmacological profile and preclinical efficacy support its advancement as a development candidate, alone and in combination for obesity treatment, potentially offering a novel, convenient, and accessible therapeutic option."

Late-breaking abstract • Metabolic Disorders • Obesity

Structure Therapeutics Announces...Late-Breaking Poster Presentations at the American Diabetes Association 85th Scientific Sessions Including New Preclinical Data for Oral Small Molecule Amylin Agonist, ACCG-2671 (GlobeNewswire) - "Structure Therapeutics...announced two upcoming late-breaking poster presentations at the American Diabetes Association 85th Scientific Sessions....“We believe ACCG-2671...is expected to enter clinical development by the end of 2025'....'The preclinical data being presented at ADA include the robust weight-loss effects of ACCG-2671 alone and in combination with a GLP-1 receptor agonist underscoring ACCG-2671’s potential as a future small molecule backbone treatment for obesity'."

Late-breaking abstract • Preclinical • Obesity

Structure Therapeutics Reports First Quarter 2025 Financial Results and Recent Highlights (GlobeNewswire) - "Recent and Upcoming Milestones: Aleniglipron (GSBR-1290); The Phase 2b ACCESS and ACCESS II studies are fully enrolled and on track for topline 36-week data by year-end 2025....ACCG-2671: Investigational new drug (IND) enabling activities for ACCG-2671 are ongoing; Structure Therapeutics plans to initiate a first-in-human Phase 1 clinical study by year-end 2025. New preclinical data for ACCG-2671 will be presented in a late-breaking poster session at the American Diabetes Association (ADA) 85th Scientific Sessions on June 22, 2025....Structure Therapeutics is evaluating ANPA-0073, a Phase 2 ready biased APJR agonist for potential selective or muscle-sparing weight loss....Long term chronic GLP-toxicology studies are currently underway and expected to be completed in 2025....Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $42.9 million, as compared to $20.7 million for the same period in 2024."

Commercial • New P1 trial • P2b data • Preclinical • Trial completion date • Obesity

Structure Therapeutics Announces Selection of Lead Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity (GlobeNewswire) - "Structure Therapeutics...announced the selection of its lead oral small molecule amylin receptor agonist, ACCG-2671. Amylin is a hormone that plays an important role in regulating glycemia and energy balance and is recognized as a promising therapeutic target for obesity and related diseases....ACCG-2671 was designed as an oral small molecule Dual Amylin and Calcitonin Receptor Agonist (DACRA) and is expected to enter Phase 1 clinical development by year end 2025....In preclinical studies, ACCG-2671 demonstrated potent and balanced in vitro activities toward the key amylin receptor and the calcitonin receptor. ACCG-2671 also further demonstrated robust in vivo efficacy and a pharmacokinetic (PK) and safety profile supporting once-daily oral dosing in humans."

New P1 trial • Pipeline update • Preclinical • Obesity