NCT06194188

A Phase 2 Clinical Study of CU-20401

A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of CU-20401 for Injection in Moderate to Severe Contour Protuberance or Excessive Enrichment Due to Submental Fat (SMF) Accumulation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	Subcutaneous injection of CU-20401	Reconstitute the product with 0.9% sodium chloride solution for injection, respectively, before use, for a single subcutaneous injection in the submental fat area.

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-09-02
• Completion: 2024-09-02
• First posted: 2024-01-08
• Last updated: 2025-01-22

Locations

1 site across 1 country: China