ASC30 / Ascletis - LARVOL DELTA

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

Abstract Title: A full analysis of 28-Day MAD Study of Oral GLP-1R Biased Small Molecule Agonist ASC30 for obesity (PRNewswire) - "Ascletis Presents Full Analysis of Phase Ib Study of ASC30 Oral Tablet...at ObesityWeek 2025....Body weight changes from baseline were 6.3% reduction (multiple ascending dose (MAD) 2, n=8, 40 mg), 4.3% reduction (MAD 1, n=7, 20 mg), and 0.2% increase (placebo, n=6). No plateau was observed at Day 29. Body weight change from baseline was 4.8% reduction for MAD 3 (n=7, 60 mg), with the maximum body weight change being 9.3% reduction in this cohort."

P1 data • Obesity

Ascletis to Present Study Results of ASC30 Oral Tablet, ASC30 Injection, and Combination of ASC31 and ASC47 at ObesityWeek 2025 (PRNewswire)

P1 data • Preclinical • Obesity

Ascletis Completes Enrollment in U.S. Phase IIa Study for Its Once-Monthly Subcutaneous Depot Treatment Formulation of Small Molecule GLP-1R Agonist ASC30 for Obesity (PRNewswire) - "All 65 participants are obese or overweight with at least one weight-related comorbidity....The 12-week U.S. Phase IIa study is evaluating the efficacy, safety and tolerability of the once-monthly subcutaneous (SQ) depot formulation (treatment formulation) of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 in 65 participants with obesity or overweight....Topline data from the 12-week Phase IIa study of ASC30 once-monthly SQ depot treatment formulation are expected in the first quarter of 2026."

Enrollment closed • P2a data • Obesity

Ascletis Presented Results from Cohorts 1 and 2 of 28-day Multiple Ascending Dose Study of Its Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting (PRNewswire) - "ASC30 once-daily oral tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment in MAD cohort 2 (weekly titrations of 2 mg, 10 mg, 20 mg, and 40 mg). ASC30 once-daily oral tablet also demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment in MAD cohort 1 (weekly titrations of 2 mg, 5 mg, 10 mg, and 20 mg)."

P1 data • Obesity

ASC30, an oral GLP-1R biased small molecule agonist demonstrated superior weight loss in participants with obesity: a 28-day multiple ascending dose study (EASD 2025) - P1 | "In this MAD study, ASC30 once-daily oral tablet administration induced statistically significant body weight reductions versus placebo, with mean percent body weight changes from baseline of -4.3% and -6.3% in cohorts 1 and 2, respectively, after 28 days of oral dosing. ASC30 tablets exhibited a favorable tolerability profile. These findings position the ASC30 once-daily oral tablet as a promising investigational agent for weight management, supporting further evaluation in future clinical trials."

Metabolic Disorders • Obesity

Ascletis Announces Ultra-Long-Acting Subcutaneous Depot Maintenance Formulation of Small Molecule GLP-1R Agonist ASC30 Demonstrated an Observed Half-Life of 75 Days in Participants with Obesity (PRNewswire) - "After a single SQ injection of ASC30 (100 mg) maintenance formulation in eight participants with obesity, the median time for ASC30 to reach maximum concentrations (Cmax) was 17 days post-dose. The time for ASC30 concentrations to reduce to fifty percent (50%) of ASC30's Cmax was approximately 75 days post-dose, demonstrating an observed half-life of 75 days...Tolerability is key to maintenance therapies. During the 12-week period after a single SQ injection of ASC30 (100 mg) maintenance formulation, incidence rates of vomiting, nausea, diarrhea and constipation in ASC30-treated patients (N=8) were 0.0%, 0.0%, 12.5% and 12.5%, respectively, compared to 0.0%, 12.5%, 6.3% and 0.0%, in placebo-treated patients (N=16)."

P1 data • Obesity

Ascletis to Present 28-day Multiple Ascending Dose Study Results of Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting (PRNewswire) - "Ascletis to present data from the U.S. Phase Ib clinical study of ASC30 oral tablet in oral discussion."

P1 data • Obesity

Topline data from the Ascletis' U.S. Phase IIa study for ASC30 in participants with obesity or overweight are expected in the fourth quarter of 2025 (PRNewswire)

P2a data • Obesity

Ascletis Announces Favorable and Differentiated Pharmacokinetic Profile of ASC30 Oral Once-Daily Tablet in Its U.S. Phase Ib Multiple Ascending Dose Study (PRNewswire) - "At steady state, ASC30 demonstrated drug exposures (area under the curve over 0-24 hours or AUC0-24h) of 3,560 ng•h/mL and 5,060 ng•h/mL for cohort 1 (20 mg) and cohort 2 (40 mg) , respectively, in the Phase Ib MAD study. These drug exposure data are consistent with placebo-adjusted mean body weight reduction from baseline of 4.5% for cohort 1 (20 mg) and 6.5% for cohort 2 (40 mg) after 28-day treatment."

P1 data • Obesity

Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30 (PRNewswire) - "Ascletis Pharma...announces today that the first participants with obesity or overweight with at least one weight-related comorbidity have been dosed in its U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity (NCT06679959)....The Phase IIa study of ASC30 once-monthly SQ depot formulation is a 12-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the safety, tolerability and efficacy in participants with obesity (body mass index (BMI) ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2 but < 30 kg/m2) with at least one weight-related comorbidity. The study consists of three cohorts of different doses, with a total of approximately 65 participants. Topline data are expected in the first quarter of 2026."

P2a data • Trial status • Obesity

Ascletis Announces First Participants with Obesity or Overweight Dosed in a U.S. 13-week Phase IIa Study of Small Molecule Oral GLP-1R Agonist ASC30 (PRNewswire) - "Ascletis Pharma...announces today that the first participants with obesity or overweight with at least one weight-related comorbidity have been dosed in a U.S. 13-week Phase IIa study of small molecule oral GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity (NCT07002905). The Phase IIa study is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability in participants with obesity (body mass index (BMI) ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2 but < 30 kg/m2) with at least one weight-related comorbidity....'We are looking forward to the topline data from this Phase IIa study in the fourth quarter 2025'."

P2a data • Trial status • Obesity

Ascletis Pharma Faces Patent Challenge from CSPC Subsidiary (TipRanks) - "Ascletis Pharma Inc. announced that Conjupro Biotherapeutics, a subsidiary of CSPC Pharmaceutical Group, has filed a petition with the USPTO challenging the validity of one of Ascletis’ U.S. patents. This patent, crucial for the development of Ascletis’ drug candidate ASC30, is under review, and Ascletis is committed to defending its intellectual property rights. The company continues its operations unaffected while monitoring the situation closely."

Patent • Obesity

Ascletis Pharmaceuticals-B (1672.HK): Innovative pipeline presented at ADA conference, the company's subsequent development is worth looking forward to [Google translation] (Eastmoney.com) - P1 | N=72 | NCT06680440 | Sponsor: Ascletis Pharma (China) Co., Limited| "ASC30 SAD study demonstrates excellent safety and good pharmacokinetic properties...ASC30 has good pharmacokinetic characteristics and excellent safety. In the SAD study of ASC30, a total of 30 subjects were included and divided into 5 groups, with doses of 2mg, 5mg, 10mg, 20mg and 40mg respectively. After administration, it can be observed that the half-life of the 5-40mg group is between 30-55 hours, indicating that the product has a long half-life characteristic, which is conducive to drug development....At the same time, it can be seen that AUC increases with the increase of dose, indicating that the product has good pharmacokinetic characteristics. It is safe and convenient. After administration, the side effects of the product are all mild to moderate, and no vomiting occurred in the 2mg and 5mg dose groups."

P1 data • PK/PD data • Obesity

ASC30, an Oral GLP-1R Biased Small Molecule Agonist in Participants with Obesity—A First-in-Human Single Ascending Dose Study (ADA 2025) - "ASC30 tablet exhibited a good safety and tolerability profile in this SAD study. Based on its superior PK profile, enhanced potency as a GLP-1 RA, and favorable safety profile, ASC30 tablet once-daily, has the potential to be the best-in-class oral GLP-1R small molecule agonist."

P1 data • Metabolic Disorders • Obesity

Ascletis Announces Poster Presentations on the Study Results of ASC30 and ASC47 at the 85th Scientific Sessions of American Diabetes Association (ADA) (PRNewswire) - "Ascletis Pharma Inc...announces that poster presentations on preliminary studies of its oral small molecule GLP-1 Receptor (GLP-1R) agonist ASC30 and adipose-targeted, muscle-preserving weight loss drug candidate ASC47 will be presented at the 85th Scientific Sessions of American Diabetes Association (ADA) in Chicago, U.S....ASC30 is a new chemical entity (NCE), with U.S. and global compound patent protection until 2044."

P1/2 data • Patent • Preclinical • Obesity