Efficacy and Safety Clinical Trial
Official title:
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
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.
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04759534 -
Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia
|
Phase 3 | |
| Not yet recruiting |
NCT05532111 -
Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial
|
N/A | |
| Active, not recruiting |
NCT04284215 -
Efficacy and Safety of Albumin Paclitaxel Combined With Cisplatin Chemoradiotherapy for Non-resectable Stage III NSCLC
|
N/A | |
| Completed |
NCT06202456 -
A Phase IV Study of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver
|
Phase 4 | |
| Completed |
NCT04870606 -
Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness
|
Phase 3 | |
| Completed |
NCT03660761 -
Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03794778 -
Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer
|
Phase 4 | |
| Recruiting |
NCT03255343 -
Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim
|
N/A | |
| Recruiting |
NCT04197544 -
Evaluation of the Implantation of the End-vascular Creation of the Arteriovenous Fistulas in Patients in the University Hospital of Araba. Pilot Study.
|
N/A | |
| Recruiting |
NCT04518501 -
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03779776 -
The Efficacy and Safety of Early Vitamin AD Supplementation in Very Preterm Infants
|
N/A | |
| Not yet recruiting |
NCT06218004 -
Envafolimab Combined With Chemotherapy in Neoadjuvant and Conversion Therapy for Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Enrolling by invitation |
NCT02809079 -
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
|
Phase 4 | |
| Recruiting |
NCT03901235 -
MSC Intratissular Injection in Crohn Disease Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT03826004 -
Clemastine in Cardiovascular Surgery
|
N/A | |
| Active, not recruiting |
NCT03623776 -
Neoadjuvant JS001, or JS001 in Combination With Pemetrexed and Carboplatin in Resectable NSCLC.
|
Phase 2 | |
| Recruiting |
NCT04078399 -
Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Post-transplant Recurrence
|
N/A | |
| Not yet recruiting |
NCT06383078 -
HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer
|
Phase 2 | |
| Withdrawn |
NCT05481775 -
Evaluating Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer
|
Phase 2 |