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A Phase 2 Clinical Study of CU-20401

NCT06194188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-01-22

No results posted yet for this study

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.

Conditions

  • Efficacy and Safety

Interventions

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.

Sponsors & Collaborators

  • Cutia Therapeutics（Wuxi）Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • byron Zhu, MD · CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2024-09-02
Completion
2024-09-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06194188 on ClinicalTrials.gov