Caliway Biopharmaceuticals (Caliway) completed CBL-514 Phase 2b study for non-surgical fat reduction (CBL-0205, clinicaltrials.gov ID: NCT06005441) on October 22nd, 2024, with the topline results anticipated in Q1 2025. CBL-0205, the last of the two CBL-514 Phase 2b studies for fat reduction, was designed in accordance with the U.S.

Caliway Biopharmaceuticals（Caliway）于2024年10月22日完成了非手术减肥的CBL-514 2b期研究（CBL-0205，clinicaltrials.gov ID:NCT06005441），预计2025年第一季度将取得最终结果。CBL-0205是两项CBL-514 2b期减脂研究中的最后一项，是根据美国。

FDA recommendations for the upcoming Pivotal Phase 3 study. The possible success of two Phase 2b studies meeting endpoints will make CBL-514 the first fat reduction product for large area to enter the Phase 3 study.CBL-514 is a combination of multiple APIs, including CBL-A1 and CBL-A2. The CBL-0205 study is a multicenter, single-blinded, randomized, placebo-controlled Phase 2b trial designed to evaluate the efficacy, safety, and tolerability of CBL-514 versus its individual API, CBL-A1 and CBL-A2, as well as the placebo.

FDA对即将到来的关键性3期研究的建议。两项符合终点的2b期研究的可能成功将使CBL-514成为第一个进入3期研究的大面积减肥产品。CBL-514是多种API的组合，包括CBL-A1和CBL-A2。CBL-0205研究是一项多中心，单盲，随机，安慰剂对照的2b期临床试验，旨在评估CBL-514与其单独API，CBL-A1和CBL-A2以及安慰剂的疗效，安全性和耐受性。

A total of 173 participants were enrolled and randomly allocated to four groups to receive up to four courses of CBL-514, CBL-A1, CBL-A2, or placebo treatment, respectively, once every three weeks.Currently, there are two CBL-514 Phase 2b studies (CBL-0204 and CBL-0205) for subcutaneous fat reduction with the topline results anticipated, in Q4 2024 and Q1 2025, respectively.

共有173名参与者被纳入研究，随机分为四组，每三周接受一次CBL-514，CBL-A1，CBL-A2或安慰剂治疗四个疗程。目前，有两项CBL-514 2b期研究（CBL-0204和CBL-0205）用于皮下脂肪减少，预计分别在2024年第四季度和2025年第一季度取得最终结果。

Both these trials were designed to simulate the Phase 3 study by using the same efficacy assessment tools, Magnetic Resonance Imaging (MRI) and Abdominal Fat Reduction Scale (AFRS, a scale recommended by the U.S. FDA, developed by Caliway), to increase the success of meeting Phase 3 endpoints. Moreover, to minimize potential biases in the single-blinded design, both Phase 2b trials’ MRI readings and analyses underwent blinded Outcomes Assessor from independent organization, before being finalized by the CRO for statistical analysis.In January 2024, Caliw.

这两项试验均旨在通过使用相同的疗效评估工具，磁共振成像（MRI）和腹部脂肪减少量表（AFRS，美国FDA推荐的量表，由Caliway开发）来模拟3期研究，以提高满足3期终点的成功率。此外，为了最大程度地减少单盲设计中的潜在偏差，2b期试验的MRI读数和分析均接受了独立组织的盲法结果评估员，然后由CRO最终确定进行统计分析。2024年1月，Caliw。