ASC30 / Ascletis - LARVOL DELTA

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

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 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

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

New P2 trial • 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 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited | Phase classification: P1 ➔ P1/2 | N=46 ➔ 115 | Trial completion date: Feb 2025 ➔ Apr 2026 | Trial primary completion date: Feb 2025 ➔ Apr 2026

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Ascletis Pharma (China) Co., Limited | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Ascletis Announces…Submission of 13-week Phase IIa Study Protocol to FDA (PRNewswire) - "The 13-week Phase IIa study protocol, which has a low starting dose and slow weekly titration to the desired maintenance doses, has been submitted to the U.S. Food and Drug Administration (FDA) following a preliminary consultation with FDA. The Company expects to initiate the 13-week Phase IIa study in the U.S. at the beginning of the third quarter of 2025."

FDA event • New P2a trial • Obesity

Ascletis Announces Positive Topline Results of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30… (PRNewswire) - P1b | N=78 | NCT06680440 | Sponsor: Ascletis Pharma (China) Co., Limited | "Ascletis Pharma...announces today positive topline results of its randomized, double-blind, placebo-controlled Phase Ib multiple ascending dose (MAD) study (NCT06680440), conducted in the U.S., of ASC30 oral once-daily tablet in participants with obesity (body mass index (BMI): 30-40 kg/m2)....ASC30 oral once-daily tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 10 mg, 20 mg, and 40 mg doses. ASC30 oral once-daily tablet also demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 5 mg, 10 mg, and 20 mg doses. No vomiting was seen in this dose group. Data from three different weekly titration schemes in the Phase Ib trial support utilizing a 'lower starting dose and slower titration' strategy..."

P1 data • Obesity

Ascletis Announces Positive Interim Results from Its U.S. Phase Ib Trial with ASC30, a Potentially First-in-Class Subcutaneous Injection Small Molecule GLP-1R Agonist (PRNewswire) - P1b | N=46 | NCT06679959 | Sponsor: Ascletis Pharma (China) Co., Limited | "Ascletis Pharma....today announces positive interim results from its randomized, double-blind, placebo-controlled Phase Ib single subcutaneous (SQ) injection study (NCT06679959), conducted in the U.S., of small molecule ASC30 with three ultra-long-acting SQ injection formulations in patients with obesity (body mass index (BMI): 30-40 kg/m2). The Phase Ib study investigated the half-life of three ultra-long-acting SQ injection formulations of ASC30 (100 mg, single injection), a small molecule GLP-1 receptor (GLP-1R) agonist, developed from Ascletis' ultra-long-acting platform (ULAP). In each cohort, eight patients received one formulation of ASC30 SQ injection and two patients were on volume-matched placebo."

P1 data • Obesity

Ascletis Pharma to Host Obesity Portfolio Webinar on April 2, 2025 (PRNewswire) - "Ascletis Pharma Inc...announces it will host an Obesity Portfolio Webinar on April 2, 2025, from 9:00 a.m. – 10:30 a.m. ET....The event will include a detailed discussion on Ascletis' obesity portfolio including exciting data about its potential best-in-class clinical stage GLP-1R biased small molecule agonist, ASC30, for both once daily oral tablet and once monthly subcutaneous injection administration. Jinzi Jason Wu, Ph.D., Founder, Chairman & CEO of Ascletis, and John Gargiulo, MBA, Chief Business Officer of Ascletis, will host Q&A immediately following the presentation."

Clinical data • Obesity

Ascletis Announces Positive Interim Results from First Two Cohorts of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30 (PRNewswire) - P1 | N=78 | NCT06680440 | Sponsor: Ascletis Pharma (China) Co., Limited | "Mean body weight reductions from baselines were 4.3% and 6.3% for MAD cohorts 1 and 2, respectively, after 28-day treatment with ASC30 oral once-daily tablets. Placebo-adjusted mean body weight reductions from baselines were 4.2% and 6.2% for MAD cohorts 1 and 2, respectively. ASC30 was generally well tolerated in MAD cohorts 1 and 2, with a favorable safety profile. There were no serious adverse events (SAEs). All gastrointestinal (GI)-related adverse events (AEs) were mild (grade 1) or moderate (grade 2). Weekly titrations of ASC30 improved GI tolerability."

P1 data • Obesity

Ascletis Announces Positive Results from U.S. Phase Ia Single Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30... (PRNewswire) - P1a | N=78 | NCT06680440 | Sponsor: Ascletis Pharma (China) Co., Limited | "Ascletis Pharma Inc...announces today positive topline results from its U.S. single ascending dose (SAD) study (NCT06680440) of ASC30 oral tablet in patients with obesity (body mass index (BMI): 30-40 kg/m2)....In Cohort 5, 40 mg ASC30 oral tablet single dose was given orally to patients with obesity under both fasting and fed conditions. The data indicated that ASC30 oral tablet's PK properties including AUC and t1/2 were essentially identical in the absence or presence of food, suggesting that ASC30 oral tablet can offer patient-friendly, once-daily oral dosing without food and water restrictions. ASC30 oral tablet was generally safe and well tolerated in the Phase Ia SAD study. All adverse events (AEs) were mild (grade 1) or moderate (grade 2), and most of the AEs were gastrointestinal (GI)-related. There were no grade 3 or higher AEs, as well as no serious AEs (SAEs)."

P1 data • Obesity

ASC30 Oral Tablet U.S. Phase Ib MAD Study Update (PRNewswire) - "The ASC30 oral tablet MAD study consists of 3 cohorts with weekly titrations in which patients with obesity are treated for 28 days with ASC30 oral tablet once daily or placebo. Cohort 1 (2 mg, 5 mg, 10 mg and 20 mg) has been completed. Cohort 2 (2 mg, 10 mg, 20 mg and 40 mg) and Cohort 3 (5 mg, 15 mg, 30 mg and 60 mg) are expected to be completed in late February and March 2025, respectively. Topline results from the MAD study, including weight loss, safety and PK, are expected by the end of March 2025."

P1 data • Trial status • Obesity

Ascletis is...developing ASC30, a GLP-1 receptor (GLP-1R) biased small molecule that can be dosed once daily orally or once monthly subcutaneously (PRNewswire) - "Both ASC30 once-daily oral tablet (NCT06680440) and ASC30 once-monthly SQ injection (NCT06679959) are currently in Phase Ib clinical trials in the U.S. for the treatment of obesity, with topline data expected in the first quarter of 2025."

P1 data • Metabolic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited

New P1 trial • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Injection in Participants With Obesity (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited

New P1 trial • Genetic Disorders • Obesity