ASC47 / Ascletis - LARVOL DELTA

Ascletis Completes Dosing of All Participants in Its U.S. Clinical Study Combining Adipose-Targeted, Once-Monthly Injectable Small Molecule THRβ Agonist, ASC47, and Semaglutide for the Treatment of Obesity (PRNewswire) - "Ascletis Pharma...announces that all the 28 participants have recently been dosed in the randomized, double-blind, placebo-controlled study (ASC47-103 study, NCT06972992) evaluating the safety, tolerability and preliminary efficacy at Day 29 of single-dose, ultra-long-acting subcutaneously (SQ) administered ASC47 in combination with semaglutide in participants with obesity who do not have type 2 diabetes. The total time to enroll all the 28 participants was less than two months. The study, conducted in the U.S., consists of three cohorts with single ascending doses (10 mg, 30 mg and 60 mg) of ASC47 or volume-matched placebo. Participants in each cohort also receive four doses of semaglutide (0.5 mg, once weekly)....Topline data from this combination study of ASC47 with semaglutide are expected in the fourth quarter of 2025."

P1 data • Trial status • Obesity

ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Obesity, in Combination with Semaglutide, Demonstrated Superior Weight Loss to Semaglutide Monotherapy in a Preclinical Model (ADA 2025) - "ASC47 low dose combination treatments were well tolerated in obese mice and produced a significant and healthy WL."

Combination therapy • Monotherapy • Preclinical • Metabolic Disorders • Obesity

ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Obesity, in Combination with Semaglutide, Demonstrated Superior Weight Loss to Semaglutide Monotherapy in a Preclinical Model (Abstract Number: 8 47-P) (163.com) - "This study used C57BL/6J mice that were induced to obesity by a high-fat diet for 16 weeks and then received different treatment regimens for 28 days...The results showed that the low-dose ASC47 combination therapy showed a better weight loss effect than semaglutide alone, with an average total body weight reduction of 36.2%, an increase of 56.7% over monotherapy. At the end of treatment, the muscle mass percentage of obese mice in the combination treatment group (68.8%) was close to that of healthy non-obese mice (66.0%), indicating that healthy weight loss was achieved....Therefore, the low-dose ASC47 combination therapy was well tolerated in obese mice and achieved significant and healthy weight loss."

Preclinical • 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

ASC47, a Muscle-Preserving Weight Loss Drug Candidate in Healthy Participants: A First-in-human Single Ascending Dose Study (ECO 2025) - "ASC47 demonstrated target engagement, with significant reductions in lipid biomarkers (such as LDL-C and TC) observed on Day 29 after a single SQ injection."

Clinical • P1 data • Genetic Disorders • Obesity

ASC47, An Adipose-Targeted, Muscle-Preserving Weight Loss Drug Candidate For Obesity, Demonstrated Significant Weight Loss And Preserved Muscle In DIO Mice (ECO 2025) - "In a head-to-head diet-induced obese (DIO) mouse study, compared to semaglutide (30 nmol/kg, QD, SQ), a clinically relevant dose of ASC47 (45 mg/kg, Q2W, SQ) reduced total fat mass (-63.5%, p=0.007 vs semaglutide), statistically and significantly more than semaglutide (-39.6%) in a DIO mouse study ("

Preclinical • Genetic Disorders • Obesity

Ascletis Announces First Participants Dosed in a U.S. Clinical Study Combining Adipose-Targeted, Once-Monthly Injectable Small Molecule THRβ Agonist, ASC47, and Semaglutide for the Treatment of Obesity (The Manila Times) - "Ascletis Pharma Inc...announces that the first participants have been dosed in the randomized, double-blind, placebo-controlled study (ASC47-103 study) evaluating the safety and preliminary efficacy of single-dose, ultra-long-acting subcutaneously (SQ) administered ASC47 in combination with semaglutide in participants with obesity who do not have Type 2 diabetes....Topline data from the ASC47-103 study are expected in the fourth quarter of 2025."

P1 data • Trial status • Obesity

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited

New P1 trial • Genetic Disorders • Obesity

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Ascletis Pharma (China) Co., Limited | Recruiting ➔ Completed | N=60 ➔ 28 | Trial completion date: Apr 2025 ➔ Dec 2024

Enrollment change • Trial completion • Trial completion date • Obesity

Ascletis Announces…U.S. FDA Clearance of IND Application for ASC47 in Combination with Semaglutide (PRNewswire) - "The U.S. IND (Investigational New Drug) application for ASC47 in combination with semaglutide for the treatment of obesity, recently cleared by U.S. Food and Drug Administration (FDA), is supported by the...preclinical data of low dose ASC47 in combination with semaglutide and by the safety, tolerability and preliminary efficacy of the Phase Ib ASC47 monotherapy studies in Australia....The first patient is expected to be dosed by the end of the second quarter of 2025."

IND • Obesity

Ascletis Announces Positive Topline Results of Phase Ib Studies of ASC47 Monotherapy in Australia… (PRNewswire) - P1b | N=60 | NCT06427590 | Sponsor: Ascletis Pharma (China) Co., Limited | "ASC47, an adipose-targeted muscle-preserving weight loss drug candidate for the treatment of obesity, demonstrated a half-life of up to 26 days and 40 days, respectively, in Phase Ib single subcutaneous injection studies in healthy subjects with elevated LDL-C and patients with obesity, supporting once-monthly to once-bimonthly administration....ASC47 single subcutaneous injection (90 mg) in patients with obesity demonstrated a weight loss signal. Placebo-adjusted mean weight loss was 0.2% (day 29), 1.0% (day 43), and peaked at 1.7% (day 50), consistent with the speed of weight loss anticipated given ASC47's mechanism of action....The multiple ascending dose (MAD) study of ASC47 monotherapy for the treatment of obesity is expected to be initiated in the second half of 2025."

New trial • P1 data • Obesity

Ascletis Announces ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Treatment of Obesity, in Combination with Semaglutide, Demonstrated Superior Weight Loss to Semaglutide Monotherapy in a Preclinical Model (PRNewswire) - "ASC47 low dose combination 1...treatment was superior to semaglutide monotherapy (30 nmol/kg, SQ, once daily), showing an average total body weight reduction of 36.2% compared to 23.1%, achieving 56.7% more relative weight loss compared to semaglutide monotherapy...ASC47 low dose combinations with semaglutide restored the body composition of obese mice to the level of healthy non-obese mice. At the end of treatment, the percentage of total muscle mass over the total body weight of obese mice treated with ASC47 low dose combination treatments (68.8%) was similar to healthy non-obese mice (66.0%), indicating healthy weight loss...ASC47 low dose combination treatments were well tolerated in obese mice and exhibited a statistically significant reduction in levels of liver enzymes such as alanine aminotransferase (ALT) compared to vehicle treatment in obese mice."

Preclinical • Metabolic Disorders • Obesity

Interim data from a Phase I single ascending dose (SAD) study in Australia in subjects with elevated low-density lipoprotein cholesterol... (PRNewswire) - P1 | N=60 | NCT06427590 | Sponsor: Ascletis Pharma (China) Co., Limited | "Interim data...showed that ASC47, via SQ injection, demonstrated a half-life of 21 days. Further, ASC47 demonstrated a good tolerability profile up to 90 mg with no serious adverse events (SAEs) and no discontinuations due to adverse events (AEs). The majority of AEs were mild (grade 1). There were no gastrointestinal or cardiac AEs reported, as well as no abnormal liver enzymes reported (Link). The Australian SAD study is still ongoing with higher doses of ASC47...ASC47 is currently in the clinical trials of patients with obesity in Australia, with topline data of Phase IIa study expected in the second quarter of 2025."

P1 data • P2a data • Metabolic Disorders • Obesity

Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited | N=36 ➔ 60

Enrollment change • Obesity

Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Gannex Pharma Co., Ltd.

New P1 trial • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis