A Phase 2 Clinical Study of CU-20401

Status Active, not recruiting

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled Phase Ⅱ clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20401 for Injection in a population with moderate to severe contour elevation or over-fullness due to SMF accumulation.

Clinical Trial Description

Eligible subjects were randomized in a 1: 1: 1 ratio to CU-20401 low dose group (0.06 mg/dose), CU-20401 high dose group (0.08 mg/dose), or placebo group using the severity of baseline clinician-reported SMF accumulation (score 2 or 3) as a stratification factor, and received a single subcutaneous injection of this group in the submental fat region on D1; return to the hospital for efficacy assessment on D29, D57, D85 or at early withdrawal; return to the hospital for safety assessment on D1, D8, D15, D29, D57, D85 or early withdrawal; immunogenicity samples were collected on D1, D8, D15, D29, D57, D85, or at early withdrawal (the study design is shown in the figure below). ;

Study Design

Related Conditions & MeSH terms

Efficacy and Safety

Clinical Trial Details

NCT number	NCT06194188
Study type	Interventional
Source	Cutia Therapeutics(Wuxi)Co.,Ltd
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 2, 2024
Completion date	December 30, 2024

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