ASC30 / Ascletis - LARVOL DELTA

ASC30, an Oral GLP-1R Biased Small Molecule Agonist in Participants with Obesity—A First-in-Human Single Ascending Dose Study (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

P1 data • Metabolic 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