{"id":66756,"date":"2026-08-10T18:00:00","date_gmt":"2026-08-10T11:00:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=66756"},"modified":"2026-08-10T18:00:00","modified_gmt":"2026-08-10T11:00:00","slug":"ascletis-announces-initiation-of-two-phase-i-studies-in-u-s-for-the-treatment-of-obesity-asc36-once-monthly-injection-an-amylin-receptor-peptide-agonist-and-asc36_35fdc-once-monthly-injection-a-c","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=66756","title":{"rendered":"Ascletis Announces Initiation of Two Phase I Studies in U.S. for the Treatment of Obesity: ASC36 Once-Monthly Injection, an Amylin Receptor Peptide Agonist, and ASC36_35FDC Once-Monthly Injection, a Co-Formulation of ASC36 and GLP-1R\/GIPR Peptide Agonist ASC35"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

-ASC36_35FDC, a once-monthly subcutaneous (SQ) fixed dose combination (FDC) injection of ASC36 and ASC35, is a potentially first-in-class drug candidate which targets three validated targets of amylin receptor, GLP-1R and GIPR.<\/i><\/p>\n

-ASC36 is a potentially first-in-class once-monthly to once-quarterly SQ injection which targets amylin receptor.<\/i><\/p>\n

-Investigational New Drug (IND) Applications for both ASC36 injection and ASC36_35FDC were recently cleared by the U.S. Food and Drug Administration (FDA).<\/i><\/p>\n

HONG KONG<\/span>, Aug. 10, 2026<\/span> \/PRNewswire\/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that following the Investigational New Drug (IND) clearance by the U.S. Food and Drug Administration (FDA), it has initiated two Phase I studies in the U.S. for the treatment of obesity: ASC36, a once-monthly to once-quarterly next-generation amylin receptor peptide agonist and ASC36_35FDC, a once-monthly subcutaneous (SQ) fixed dose combination (FDC) injection of ASC36 and GLP-1R\/GIPR peptide agonist ASC35.<\/p>\n

<\/div>\n

The Phase I study for ASC36_35FDC is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36_35FDC injections following single and multiple ascending doses in participants with obesity (body mass index (BMI) \u2265 30.0 kg\/m\u00b2) or overweight (BMI \u2265 27.0 kg\/m\u00b2) with weight-related comorbidities. The Phase I study also evaluates two different FDC formulations: Injection A in 88 participants and Injection B in 88 participants. Both Injections A and B consist of two ultra-long-acting peptide agonists, the amylin receptor peptide agonist ASC36 and the GLP-1R\/GIPR dual peptide agonist ASC35.<\/p>\n

The Phase I study for ASC36 is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36 injections following single and multiple ascending doses in participants with obesity (BMI \u2265 30.0 kg\/m\u00b2) or overweight (BMI \u2265 27.0 kg\/m\u00b2) with weight-related comorbidities. The Phase I study also evaluates two different formulations: Injection A in 72 participants and Injection B in 72 participants.<\/p>\n

“Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32[1]<\/sup>. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. This translates into eight injections per month. In contrast, ASC36_35FDC, a potentially first-in-class SQ, FDC injection which targets amylin receptor, GLP-1R and GIPR, requires only one injection per month. More exciting, ASC36_35FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study (Press release<\/a>). These animal models are highly predictive of human efficacy,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “As we have initiated a global Phase III program for the oral small molecule GLP-1, ASC30, I am equally pleased with our significant progress in 2026 on our once-monthly SQ peptide pipeline, evidenced by initiation of three Phase I studies in the U.S. \u2013 ASC35, ASC36 and ASC36_35FDC.”<\/p>\n

Both ASC36 and ASC35 were discovered in-house utilizing Ascletis’ Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.<\/p>\n

SALD formulation is a low-viscosity solution which is composed of lipids, biocompatible organic solvents, and the active pharmaceutical ingredient (API). The low-viscosity solution can be easily administered into the subcutaneous tissue using an injection pen\/auto-injector with a fine needle as thin as 29 gauge. After SQ administration, the solution transforms into a gel-like depot in the tissue. Under the action of enzymes in the tissue, the depot slowly degrades, releasing the API over a one-month or longer period.<\/p>\n

In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration in humans. In NHP studies, ASC36_35FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans.<\/p>\n

Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, ASC36_35FDC, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide.<\/p>\n

Both ASC36 injection formulation and ASC36_35FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH.<\/p>\n

[1] <\/sup>Eli Lilly and Company. Safety, tolerability, pharmacokinetics and pharmacodynamics of eloralintide and tirzepatide co-administered as once-weekly subcutaneous injections [Abstract accepted for presentation at EASD 2026<\/a>]<\/p>\n

About Ascletis Pharma Inc.<\/b><\/p>\n

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potentially best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a once-daily oral small molecule GLP-1R agonist for chronic weight management and diabetes; ASC30_48FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC48 (GIPR agonist), ASC30_48_39FDC, a once-daily oral small molecule triple agonist, a fixed dose combination of ASC30 (GLP-1R agonist), ASC48 (GIPR agonist) and ASC39 (amylin receptor agonist (SARA)), ASC39, an eloralintide-like potent selective amylin receptor agonist (SARA) once-daily oral small molecule, ASC30_39FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC39 (amylin receptor agonist (SARA)), ASC36, an amylin peptide, designed to be administered once monthly to once quarterly subcutaneously and once daily orally, ASC35, a once-monthly subcutaneously administered GLP-1R\/GIPR dual peptide agonist, ASC36_35FDC, a once-monthly subcutaneous triple peptide agonist, a fixed combination of ASC36 (amylin receptor agonist) and ASC35 (GLP-1R\/GIPR agonist), ASC37, a GLP-1R\/GIPR\/GCGR triple peptide agonist, designed to be administered once monthly subcutaneously and once daily orally, and ASC36_37FDC, a once-monthly subcutaneous quadruple peptide agonist, a fixed dose combination of ASC36 (amylin receptor agonist) and ASC37 (GLP-1R\/GIPR\/GCGR agonist), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n

For more information, please visit www.ascletis.com<\/a>.<\/p>\n

Contact\uff1a<\/p>\n

Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com<\/a><\/p>\n

Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

-ASC36_35FDC, a once-monthly subcutaneous (SQ) fixed dose combination (FDC) injection of ASC36 and ASC35, is a potentially first-in-class drug candidate which targets three validated targets of amylin receptor, GLP-1R and GIPR.<\/i><\/p>\n

-ASC36 is a potentially first-in-class once-monthly to once-quarterly SQ injection which targets amylin receptor.<\/i><\/p>\n

-Investigational New Drug (IND) Applications for both ASC36 injection and ASC36_35FDC were recently cleared by the U.S. Food and Drug Administration (FDA).<\/i><\/p>\n

HONG KONG<\/span>, Aug. 10, 2026<\/span> \/PRNewswire\/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that following the Investigational New Drug (IND) clearance by the U.S. Food and Drug Administration (FDA), it has initiated two Phase I studies in the U.S. for the treatment of obesity: ASC36, a once-monthly to once-quarterly next-generation amylin receptor peptide agonist and ASC36_35FDC, a once-monthly subcutaneous (SQ) fixed dose combination (FDC) injection of ASC36 and GLP-1R\/GIPR peptide agonist ASC35.<\/p>\n

<\/div>\n

The Phase I study for ASC36_35FDC is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36_35FDC injections following single and multiple ascending doses in participants with obesity (body mass index (BMI) \u2265 30.0 kg\/m\u00b2) or overweight (BMI \u2265 27.0 kg\/m\u00b2) with weight-related comorbidities. The Phase I study also evaluates two different FDC formulations: Injection A in 88 participants and Injection B in 88 participants. Both Injections A and B consist of two ultra-long-acting peptide agonists, the amylin receptor peptide agonist ASC36 and the GLP-1R\/GIPR dual peptide agonist ASC35.<\/p>\n

The Phase I study for ASC36 is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36 injections following single and multiple ascending doses in participants with obesity (BMI \u2265 30.0 kg\/m\u00b2) or overweight (BMI \u2265 27.0 kg\/m\u00b2) with weight-related comorbidities. The Phase I study also evaluates two different formulations: Injection A in 72 participants and Injection B in 72 participants.<\/p>\n

“Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32[1]<\/sup>. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. This translates into eight injections per month. In contrast, ASC36_35FDC, a potentially first-in-class SQ, FDC injection which targets amylin receptor, GLP-1R and GIPR, requires only one injection per month. More exciting, ASC36_35FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study (Press release<\/a>). These animal models are highly predictive of human efficacy,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “As we have initiated a global Phase III program for the oral small molecule GLP-1, ASC30, I am equally pleased with our significant progress in 2026 on our once-monthly SQ peptide pipeline, evidenced by initiation of three Phase I studies in the U.S. \u2013 ASC35, ASC36 and ASC36_35FDC.”<\/p>\n

Both ASC36 and ASC35 were discovered in-house utilizing Ascletis’ Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.<\/p>\n

SALD formulation is a low-viscosity solution which is composed of lipids, biocompatible organic solvents, and the active pharmaceutical ingredient (API). The low-viscosity solution can be easily administered into the subcutaneous tissue using an injection pen\/auto-injector with a fine needle as thin as 29 gauge. After SQ administration, the solution transforms into a gel-like depot in the tissue. Under the action of enzymes in the tissue, the depot slowly degrades, releasing the API over a one-month or longer period.<\/p>\n

In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration in humans. In NHP studies, ASC36_35FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans.<\/p>\n

Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, ASC36_35FDC, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide.<\/p>\n

Both ASC36 injection formulation and ASC36_35FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH.<\/p>\n

[1] <\/sup>Eli Lilly and Company. Safety, tolerability, pharmacokinetics and pharmacodynamics of eloralintide and tirzepatide co-administered as once-weekly subcutaneous injections [Abstract accepted for presentation at EASD 2026<\/a>]<\/p>\n

About Ascletis Pharma Inc.<\/b><\/p>\n

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potentially best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a once-daily oral small molecule GLP-1R agonist for chronic weight management and diabetes; ASC30_48FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC48 (GIPR agonist), ASC30_48_39FDC, a once-daily oral small molecule triple agonist, a fixed dose combination of ASC30 (GLP-1R agonist), ASC48 (GIPR agonist) and ASC39 (amylin receptor agonist (SARA)), ASC39, an eloralintide-like potent selective amylin receptor agonist (SARA) once-daily oral small molecule, ASC30_39FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC39 (amylin receptor agonist (SARA)), ASC36, an amylin peptide, designed to be administered once monthly to once quarterly subcutaneously and once daily orally, ASC35, a once-monthly subcutaneously administered GLP-1R\/GIPR dual peptide agonist, ASC36_35FDC, a once-monthly subcutaneous triple peptide agonist, a fixed combination of ASC36 (amylin receptor agonist) and ASC35 (GLP-1R\/GIPR agonist), ASC37, a GLP-1R\/GIPR\/GCGR triple peptide agonist, designed to be administered once monthly subcutaneously and once daily orally, and ASC36_37FDC, a once-monthly subcutaneous quadruple peptide agonist, a fixed dose combination of ASC36 (amylin receptor agonist) and ASC37 (GLP-1R\/GIPR\/GCGR agonist), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n

For more information, please visit www.ascletis.com<\/a>.<\/p>\n

Contact\uff1a<\/p>\n

Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com<\/a><\/p>\n

Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a><\/p>\n

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