ASC30 / Ascletis - LARVOL DELTA

A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=100 | Completed | Sponsor: Ascletis Pharma (China) Co., Limited | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Ascletis Announces First Participant Dosed in a Global Phase III Clinical Program of Once-Daily Oral Small Molecule GLP-1 Receptor Agonist ASC30 for Chronic Weight Management (PRNewswire) - "The global Phase III clinical program consists of two pivotal, multicenter, randomized, double-blind, placebo-controlled Phase III trials, AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450), evaluating the long-term efficacy, safety, and tolerability of ASC30 once-daily oral tablets in approximately 4,600 participants across clinical sites in the U.S., Europe, and Canada....Ascletis expects to report topline data from the AURORA Phase III clinical program in the third quarter of 2028. The Company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2028 and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in early 2029."

EMA filing • FDA filing • P3 data: top line • Trial status • Obesity

AURORA-2: A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=1560 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

AURORA-1: A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P3 | N=3003 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

AURORA-2: A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=1560 | Not yet recruiting | Sponsor: Ascletis Pharma (China) Co., Limited

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

AURORA-1: A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P3 | N=3003 | Not yet recruiting | Sponsor: Ascletis Pharma (China) Co., Limited

New P3 trial • Genetic Disorders • Obesity

Ascletis Announces Initiation of Global Phase III for Oral Small Molecule GLP-1, ASC30... (PRNewswire) - "The Company has initiated a global Phase III program for ASC30 chronic weight management indication consisting of two pivotal global Phase III, multicenter, randomized, double-blind, placebo-controlled trials (AURORA-1 NCT07743463 and AURORA-2 NCT07743450) in a total of approximately 4,600 participants with obesity or overweight in the U.S., Europe, and Canada....The Company expects to announce topline data from the ASC30 Phase III program in the third quarter of 2028, with a U.S. FDA New Drug Application (NDA) filing expected by the end of 2028 and a European Medicines Agency (EMA) Marketing Authorisation Application (MAA) filing expected in early 2029."

EMA filing • FDA filing • P3 data: top line • Trial status • Obesity

Ascletis Selects for Clinical Development a Fixed-Dose Combination of First-in-Class Oral Small Molecule GIPR Agonist, ASC48, and Oral Small Molecule GLP-1R Agonist, ASC30 (Thailand Business News) - "ASC48 demonstrated excellent oral bioavailability and drug exposure as well as long half-life in rodents and non-human primates (NHPs), supporting once-daily oral dosing in humans; SC30_48 FDC demonstrated approximately 52% greater relative body weight reduction compared to ASC30 monotherapy in a head-to-head NHP study; Submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC30_48 FDC oral tablets is expected in the fourth quarter of 2026."

Clinical • IND • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity (clinicaltrials.gov) - P1/2 | N=115 | Completed | Sponsor: Ascletis Pharma (China) Co., Limited | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Oral Small Molecule GLP-1, ASC30, Demonstrated Placebo-Adjusted Weight Loss of 7.7% with Better Gastrointestinal Tolerability in Its 13-Week U.S. Phase II Study in Participants with Obesity (ADA 2026) - "Introduction and Objective: ASC30 is a small-molecule oral GLP-1 RA discovered by Ascletis with a similar chemical scaffold but differentiated pharmacological properties compared to orforglipron (OFG). This 13-week, randomized, double-blind, placebo-controlled, multicenter Phase II study was conducted at U.S. sites. ASC30 oral tablet showed dose-dependent weight loss with a favorable GI tolerability profile, supporting its potential as best-in-class oral GLP-1 RA."

Clinical • P2 data • Metabolic Disorders • Obesity

Oral Small-Molecule GLP-1 Receptor Agonist: ASC30 (PRNewswire) - "In a 4-week Phase I study, ASC30 demonstrated favorable safety and tolerability across all doses (20 mg, 40 mg, and 60 mg), with no hepatic safety signals or elevations in alanine transaminase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBL)....In a Phase II study (n=125), ASC30 once-daily tablets topline results showed statistically significant and clinically meaningful dose-dependent placebo-adjusted mean body weight reductions with no observed plateau for weight loss. Placebo-adjusted body weight reductions at Week 13 were 5.4%, 7.0%, and 7.7% for the 20 mg, 40 mg, and 60 mg maintenance doses, respectively....Global Phase III trials for obesity are expected to be initiated by the end of the third quarter of 2026. The Phase III program will comprise two 72-week randomized, double-blind, placebo-controlled studies in participants with obesity or overweight, with or without type 2 diabetes..."

New P3 trial • P1 data • P2 data • Obesity • Type 2 Diabetes Mellitus

Oral Small-Molecule GLP-1 Receptor Agonist: ASC30 (PRNewswire) - "In non-human primates (NHPs), ASC30 administered at 1.5 mg/kg stimulated statistically significant and substantially greater insulin secretion than OFG administered at 6 mg/kg. In an NHP study, ASC30 achieved approximately 5-fold higher oral exposure than OFG."

Preclinical • Obesity

A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Ascletis Pharma (China) Co., Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Ascletis Announces Positive Topline Results from U.S. Phase II, 24-Week Study for Its Ultra-Long-Acting Subcutaneous Depot Formulations of Small Molecule GLP-1R Agonist ASC30 for Obesity (PRNewswire) - "The Phase II study achieved its primary endpoint, with patients receiving three doses of once-monthly ASC30 SQ depot formulation A1 demonstrating a statistically significant (p < 0.05 vs placebo) and clinically meaningful placebo-adjusted mean weight loss of 6.3% at week 12. Additionally, ASC30 SQ depot formulation A1 achieved a statistically significant (p < 0.05 vs placebo) and clinically meaningful placebo-adjusted mean weight loss of 7.5% at week 16 after 3 monthly doses....ASC30 SQ depot formulation A1 achieved placebo-adjusted mean body weight loss of 2.7%, 5.5%, 6.3%, and 7.5% at week 4, week 8, week 12 and week 16, respectively."

P2 data • Obesity

Investigating the Shelf-Life Extension of Shrimp Surimi Using a Polysaccharide-Based Film from Alpinia oxyphylla. (PubMed, Foods) - "Results showed that the ASC groups (where Alpinia oxyphylla polysaccharide was added at 20%, 30%, and 40% of the sodium alginate mass, designated as ASC 20%, ASC 30%, and ASC 40%) significantly outperformed the control group across all quality indicators. It is superior to single/individual chemical preservatives in terms of film-forming ability, functionality, and safety, providing a natural, effective, and environmentally friendly preservation approach for shrimp surimi and other aquatic products. It also offers a theoretical foundation and practical reference for the development of natural preservation technologies in the food industry."

Journal • Targeted Protein Degradation

Ascletis Pharma to Raise HK$835 Million via Share Placement to Fund Obesity Drug Trials (TipRanks) - "Ascletis Pharma will place 69.26 million new shares at HK$12.18 each, a discount to market, raising significant new capital. Most of the HK$835.3 million net proceeds will fund global Phase III trials of obesity drug ASC30, bolstering Ascletis’ position in metabolic therapies."

Financing • Obesity

Ascletis Pharma…announces today that the first participants have been dosed in a U.S. 13-week Phase II study (NCT07321678) with ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of type 2 diabetes mellitus (PRNewswire) - "The Phase II study is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 tablets in participants with type 2 diabetes mellitus....The Phase II study will enroll approximately 100 participants with type 2 diabetes mellitus at multiple sites across the U.S....Topline data from the Phase II study for the treatment of diabetes are expected in the third quarter of 2026."

P2 data • Trial status • Type 2 Diabetes Mellitus

Ascletis Announces U.S. FDA IND Clearance for 13-Week Phase II Study of Its Oral Small Molecule GLP-1, ASC30, in Participants with Diabetes (PRNewswire) - "The Phase II study will enroll approximately 100 participants with type 2 diabetes mellitus at multiple sites across the U.S. Participants will be randomly assigned in a ratio of approximately 2:3:3:2 to 40 mg, 60 mg and 80 mg ASC30 tablets and matching placebo tablets, respectively....Enrollment is expected to begin in the first quarter of 2026."

IND • New P2 trial • Type 2 Diabetes Mellitus

A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants With Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=125 | Completed | Sponsor: Ascletis Pharma (China) Co., Limited | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity (clinicaltrials.gov) - P1/2 | N=115 | Active, not recruiting | Sponsor: Ascletis Pharma (China) Co., Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Ascletis' Oral Small Molecule GLP-1, ASC30, Demonstrated Placebo-Adjusted Weight Loss of 7.7% with Better Gastrointestinal Tolerability in Its 13-Week U.S. Phase II Study in Participants with Obesity or Overweight (PRNewswire) - "At 13 weeks, all three doses of ASC30 met the primary endpoint compared to placebo, demonstrating statistically significant (p values < 0.0001 for 20 mg, 40 mg and 60 mg vs placebo) and clinically meaningful weight loss. On the primary endpoint of mean percent change in body weight from baseline at 13 weeks, 60 mg ASC30 delivered a placebo-adjusted mean weight loss of 7.7%...At the 13-week primary endpoint, ASC30 once-daily tablets showed dose-dependent placebo-adjusted mean body weight reductions of 5.4%, 7.0% and 7.7% for 20 mg, 40 mg and 60 mg, respectively. No plateau was observed for weight loss. The baseline mean body weight and body mass index (BMI) of participants were 107.3 kg and 38.6 kg/m2, respectively....'We plan to submit these data to the U.S. Food and Drug Administration (FDA) and request an End-of-Phase II meeting in the first quarter of 2026.'"

FDA event • P2 data • Obesity

A Full Analysis of 28-Day MAD Study of Oral GLP-1R Biased Small Molecule Agonist ASC30 for Obesity (OBESITY WEEK 2025) - "In this MAD study, ASC30 once-daily oral tablet administration demonstrated statistically significant weight loss, with mean percent body weight changes from baseline up to -6.3% after only 28 days of oral dosing. ASC30 tablets exhibited a favorable tolerability profile. These findings position the ASC30 once-daily oral tablet as a potential best-in-class investigational agent for weight management."

Genetic Disorders • Obesity • NFKBIA

ASC30, a Once-Monthly SQ Injected Small Molecule GLP-1RA in Participants with Obesity: A Ph Ib Study (OBESITY WEEK 2025) - "As a potentially first-in-class SQ injected small molecule GLP-1R agonist, ASC30 demonstrated a 36.3-day half-life, supporting once-monthly or less frequent administration. All three evaluated formulations were well tolerated, with a favorable safety profile, minimal gastrointestinal adverse events, and no serious or grade ≥3 adverse events. This neutral-pH stable sterile solution formulation of ASC30 is advancing into further clinical trials to evaluate higher doses for obesity treatment and offering a potentially convenient, ultra-long-acting therapeutic option."

Genetic Disorders • Obesity

Abstract Title: ASC30, a Once-Monthly SQ Injected Small Molecule GLP-1RA in Participants with Obesity: A Ph Ib Study (PRNewswire) - "Ascletis Presents Full Analysis of...Phase Ib Study of ASC30 Injection...at ObesityWeek 2025....The observed half-life (time for ASC30 concentrations to reduce to fifty percent (50%) of ASC30's Cmax) reached 46 days and 75 days, for ASC30 subcutaneous (SQ) treatment formulation (Injection A) and ASC30 SQ maintenance formulation (Injection B), respectively....No SAEs or Grade ≥ 3 AEs were observed. GI-related AEs were mild to moderate."

P1 data • Obesity