{"id":28829,"date":"2025-07-28T07:02:56","date_gmt":"2025-07-28T07:02:56","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/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\/"},"modified":"2025-07-28T07:02:56","modified_gmt":"2025-07-28T07:02:56","slug":"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","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=28829","title":{"rendered":"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"},"content":{"rendered":"

–\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 First <\/i>p<\/i>articipants with obesity or <\/i>o<\/i>verweight <\/i>w<\/i>ith at least one <\/i>w<\/i>eight-<\/i>r<\/i>elated <\/i>c<\/i>omorbidity have been <\/i>d<\/i>osed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous<\/i>\u00a0(SQ)<\/i>\u00a0depot formulation of <\/i>s<\/i>mall <\/i>m<\/i>olecule GLP-1<\/span><\/i>\u00a0receptor<\/i>\u00a0a<\/i>gonist ASC30. <\/i><\/p>\n

–\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Ultra-long-acting <\/i>SQ<\/i>\u00a0depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants with obesity in the Phase Ib study, supporting once monthly administration. <\/i><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Phase Ib study also demonstrated that compared to the trough concentration of ASC30 at <\/i>D<\/i>ay 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than<\/span> 2:1.<\/i><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Topline data from <\/i>the<\/i>\u00a012-week Phase IIa study of ASC30 once-monthly <\/i>SQ <\/i>depot formulation are expected <\/i>in<\/i>\u00a0the first quarter of 2026.<\/i><\/p>\n

HONG KONG<\/span>, July 28, 2025 \/PRNewswire\/ —\u00a0Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that the first participants with obesity or overweight with at least one weight-related comorbidity have been dosed in its\u00a0U.S. 12-week Phase IIa study\u00a0with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1<\/span> receptor\u00a0(GLP-1R)\u00a0agonist ASC30 for the treatment of obesity (NCT06679959<\/a>).<\/span><\/p>\n

In the completed U.S. Phase Ib single ascending dose (SAD) study,\u00a0th<\/span>e ultra-long-acting SQ depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants\u00a0with obesity, supporting once monthly administration\u00a0(Press Release<\/a>). Furthermore, the U.S. Phase Ib SAD study demonstrated that compared to the trough concentration of ASC30 at Day 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than<\/span> 2:1. The proprietary SQ depot slow-release formulation of ASC30 was developed by Ascletis’ Ultra-Long-Acting Platform\u00a0(ULAP). Utilizing this innovative platform,\u00a0Ascletis has successfully designed and developed two small molecule SQ compounds for obesity with half-lives of 36 days (ASC30) and 40 days (ASC47) in participants with obesity. Ascletis’ ULAP technology does not have the limitations of albumin-dependent half-life extension technology, currently being applied to many incretins, which limits half-life extension to the half-life of albumin (approximately 20 days).<\/p>\n

In order to achieve acceptable tolerability for SQ dosing of incretin drugs, the peak-to-trough ratio during the<\/span> intended dosing interval<\/span> should be equal to or less than 2:1. Th<\/span>e peak-to-trough ratios of marketed semaglutide and tirzepatide are approximately 2:1 during their intended dosing interval. Achieving optimal tolerability of a once-monthly SQ incretin requires a half-life equal to or greater than the intended dosing interval. “A half-life less than the intended dosing interval will most likely result in a peak-to-trough ratio much greater than 2:1, negatively impacting tolerability. Among incretin drugs in clinical development or with market authorizations, ASC30 once-monthly SQ depot formulation is the only once-a-month incretin with a half-life greater than the intended dosing interval.” said Jinzi Jason Wu<\/span>, Ph.D., Founder, Chairman and CEO of Ascletis. \u00a0<\/p>\n

The Phase IIa\u00a0study of ASC30 once-monthly SQ depot formulation is a\u00a012-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the safety, tolerability\u00a0and\u00a0efficacy\u00a0in participants with obesity\u00a0(body mass index (BMI) \u2265 30 kg\/m2<\/sup>) or overweight (BMI \u2265 27 kg\/m2<\/sup> but < 30 kg\/m2<\/sup>) with at least one weight-related comorbidity. The study consists of three cohorts of different doses, with a total\u00a0of approximately 65 participants. Topline data are expected in the first quarter of 2026.\u00a0<\/p>\n

ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R biased agonist designed to be dosed once daily orally and once monthly subcutaneously for the treatment of obesity.<\/p>\n

About ASC30<\/b><\/p>\n

ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity\u00a0(NCE),\u00a0with U.S. and global compound patent\u00a0protection\u00a0until 2044 without patent extensions.\u00a0<\/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 potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery\u00a0(AISBDD) Platform and Ultra-Long-Acting Platform (ULAP), Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist in development as a once-daily oral tablet and once-monthly subcutaneous injection for weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n

To learn more about Ascletis, please visit www.ascletis.com<\/a>.<\/p>\n

Contact\uff1a
Peter Vozzo<\/span>
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<\/span>)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a>\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

–\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 First <\/i>p<\/i>articipants with obesity or <\/i>o<\/i>verweight <\/i>w<\/i>ith at least one <\/i>w<\/i>eight-<\/i>r<\/i>elated <\/i>c<\/i>omorbidity have been <\/i>d<\/i>osed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous<\/i>\u00a0(SQ)<\/i>\u00a0depot formulation of <\/i>s<\/i>mall <\/i>m<\/i>olecule GLP-1<\/span><\/i>\u00a0receptor<\/i>\u00a0a<\/i>gonist ASC30. <\/i><\/p>\n

–\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Ultra-long-acting <\/i>SQ<\/i>\u00a0depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants with obesity in the Phase Ib study, supporting once monthly administration. <\/i><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Phase Ib study also demonstrated that compared to the trough concentration of ASC30 at <\/i>D<\/i>ay 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than<\/span> 2:1.<\/i><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Topline data from <\/i>the<\/i>\u00a012-week Phase IIa study of ASC30 once-monthly <\/i>SQ <\/i>depot formulation are expected <\/i>in<\/i>\u00a0the first quarter of 2026.<\/i><\/p>\n

HONG KONG<\/span>, July 28, 2025 \/PRNewswire\/ —\u00a0Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that the first participants with obesity or overweight with at least one weight-related comorbidity have been dosed in its\u00a0U.S. 12-week Phase IIa study\u00a0with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1<\/span> receptor\u00a0(GLP-1R)\u00a0agonist ASC30 for the treatment of obesity (NCT06679959<\/a>).<\/span><\/p>\n

In the completed U.S. Phase Ib single ascending dose (SAD) study,\u00a0th<\/span>e ultra-long-acting SQ depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants\u00a0with obesity, supporting once monthly administration\u00a0(Press Release<\/a>). Furthermore, the U.S. Phase Ib SAD study demonstrated that compared to the trough concentration of ASC30 at Day 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than<\/span> 2:1. The proprietary SQ depot slow-release formulation of ASC30 was developed by Ascletis’ Ultra-Long-Acting Platform\u00a0(ULAP). Utilizing this innovative platform,\u00a0Ascletis has successfully designed and developed two small molecule SQ compounds for obesity with half-lives of 36 days (ASC30) and 40 days (ASC47) in participants with obesity. Ascletis’ ULAP technology does not have the limitations of albumin-dependent half-life extension technology, currently being applied to many incretins, which limits half-life extension to the half-life of albumin (approximately 20 days).<\/p>\n

In order to achieve acceptable tolerability for SQ dosing of incretin drugs, the peak-to-trough ratio during the<\/span> intended dosing interval<\/span> should be equal to or less than 2:1. Th<\/span>e peak-to-trough ratios of marketed semaglutide and tirzepatide are approximately 2:1 during their intended dosing interval. Achieving optimal tolerability of a once-monthly SQ incretin requires a half-life equal to or greater than the intended dosing interval. “A half-life less than the intended dosing interval will most likely result in a peak-to-trough ratio much greater than 2:1, negatively impacting tolerability. Among incretin drugs in clinical development or with market authorizations, ASC30 once-monthly SQ depot formulation is the only once-a-month incretin with a half-life greater than the intended dosing interval.” said Jinzi Jason Wu<\/span>, Ph.D., Founder, Chairman and CEO of Ascletis. \u00a0<\/p>\n

The Phase IIa\u00a0study of ASC30 once-monthly SQ depot formulation is a\u00a012-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the safety, tolerability\u00a0and\u00a0efficacy\u00a0in participants with obesity\u00a0(body mass index (BMI) \u2265 30 kg\/m2<\/sup>) or overweight (BMI \u2265 27 kg\/m2<\/sup> but < 30 kg\/m2<\/sup>) with at least one weight-related comorbidity. The study consists of three cohorts of different doses, with a total\u00a0of approximately 65 participants. Topline data are expected in the first quarter of 2026.\u00a0<\/p>\n

ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R biased agonist designed to be dosed once daily orally and once monthly subcutaneously for the treatment of obesity.<\/p>\n

About ASC30<\/b><\/p>\n

ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity\u00a0(NCE),\u00a0with U.S. and global compound patent\u00a0protection\u00a0until 2044 without patent extensions.\u00a0<\/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 potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery\u00a0(AISBDD) Platform and Ultra-Long-Acting Platform (ULAP), Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist in development as a once-daily oral tablet and once-monthly subcutaneous injection for weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n

To learn more about Ascletis, please visit www.ascletis.com<\/a>.<\/p>\n

Contact\uff1a
Peter Vozzo<\/span>
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<\/span>)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a>\u00a0<\/p>\n

<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-28829","post","type-post","status-publish","format-standard","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/28829","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=28829"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/28829\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=28829"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=28829"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=28829"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}