–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The 12-week <\/i>U.S. Phase IIa study is evaluating the efficacy, safety and tolerability of<\/i>\u00a0the <\/i>once-monthly subcutaneous<\/i>\u00a0(SQ)<\/i>\u00a0depot formulation (treatment formulation) of <\/i>s<\/i>mall <\/i>m<\/i>olecule GLP-1<\/i>\u00a0receptor<\/i>\u00a0(<\/i>GLP-1R)<\/i>\u00a0a<\/i>gonist ASC30<\/i>\u00a0in 65 participants with obesity or overweight.<\/i><\/p>\n
–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The u<\/i>ltra-long-acting <\/i>SQ<\/i>\u00a0depot treatment formulation of small molecule ASC30 demonstrated a 46-day observed 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 Topline data from the 12-week Phase IIa study of ASC30 once-monthly SQ depot treatment formulation are expected in the first quarter of 2026.<\/i><\/p>\n
–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 The <\/i>Company <\/i>will <\/i>host <\/i>a<\/i>\u00a0conference call <\/i>in Mandarin today <\/i>at <\/i>10:00 a.m.<\/span> China Standard Time.<\/i>\u00a0<\/p>\n HONG KONG<\/span><\/span>, Oct. 20, 2025<\/span><\/span> \/PRNewswire\/ — Ascletis\u00a0Pharma Inc. (HKEX: 1672, “Ascletis”) announces\u00a0the recent\u00a0completion of enrollment in the U.S. Phase IIa study for its once-monthly subcutaneous\u00a0(SQ)\u00a0depot formulation (treatment formulation) of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for\u00a0the\u00a0treatment\u00a0of\u00a0obesity\u00a0(NCT06679959<\/a>). All 65\u00a0participants are obese or overweight with at least one weight-related comorbidity.<\/p>\n The Phase IIa\u00a0study\u00a0of ASC30 once-monthly SQ depot treatment formulation is a\u00a012-week, randomized, double-blind, placebo-controlled and multi-center study conducted in the U.S. 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 65 participants. Topline data are expected in the first quarter of 2026.<\/p>\n The ultra-long-acting SQ depot treatment formulation of small molecule ASC30 demonstrated a 46-day observed half-life (as measured by time to 50% Cmax<\/sub>) in participants with obesity in the Phase Ib study\u00a0(NCT06679959<\/a>), supporting once-monthly administration.\u00a0ASC30 treatment formulation’s terminal half-life was 36 days.<\/p>\n Furthermore, the U.S. Phase Ib single ascending dose (SAD) study demonstrated that compared to the trough concentration of ASC30 at Day 29, the ultra-long-acting SQ depot treatment formulation showed a peak-to-trough ratio of approximately 1.5 to\u00a01.\u00a0The proprietary SQ depot slow-release treatment formulation of ASC30 was developed from\u00a0Ascletis’ Ultra-Long-Acting Platform\u00a0(ULAP). Ascletis’ ULAP technology does not have the limitations of albumin-dependent half-life extension technology, currently being applied to many peptide drugs and candidates, which limits half-life extension to the half-life of albumin (approximately 20 days).<\/p>\n “Completing enrollment in this study is an important milestone, marking significant progress in our development of this innovative therapy,” said Jinzi Jason Wu<\/span>, Ph.D., Founder, Chairman and CEO of Ascletis, “Ascletis’ proprietary ultra-long-acting SQ depot treatment formulation of ASC30, with its 46-day observed half-life and favorable peak-to-trough ratio of approximately 1.5 to 1, demonstrated the potential to become a once-monthly treatment option for obesity. We are looking forward to topline data from this Phase IIa study\u00a0in\u00a0the first quarter of 2026.”<\/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 administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy\u00a0and a maintenance therapy for chronic weight management.<\/p>\n Conference Call<\/b><\/p>\n Ascletis will host a conference call\u00a0in Mandarin today, October 20<\/span>, 2025\u00a0at 10:00 a.m.\u00a0China\u00a0Standard Time. A live webcast of the call will be\u00a0available via Tecent Meeting\/ VooV Meeting, with the Meeting ID: 216-282-339, or access links of:<\/p>\n Chinese Mainland [1]<\/sup>: https:\/\/meeting.tencent.com\/dm\/8LbPT9Fs9HoW<\/a>; or
International: https:\/\/voovmeeting.com\/dm\/8LbPT9Fs9HoW<\/a>.<\/p>\n