A Phase 2 Clinical Study of CU-20401

NCT06194188 | Completed Phase 2

• 1 other identifier: CU-20401-203
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

immunogenicity; SMF

Outcome Measures

Primary Outcomes (1)

• change in both CR-SMFRS score and PR-SMFRS score at the same time

  at least 1 point change in both clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score 爱at the same time. CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few，4=a lot

  Day 29

Secondary Outcomes (9)

• Proportion of subjects with at least 1 point change in CR-SMFRS score and PR-SMFRS score

  Day 57/ Day 85

• Proportion of subjects with at least 2 points change in CR-SMFRS score and PR-SMFRS score

  Day 29/Day 57/Day 85

• change from baseline in CR-SMFRS score

  Day 29/Day 57/Day 85

• change from baseline in PR-SMFRS score

  Day 29/Day 57/Day 85

• Change from baseline in the total score of PR-SMFIS

  Day 29/Day 57/Day 85

Study Arms (3)

Low Dose Group

EXPERIMENTAL

0.06mg/ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation

Drug: Subcutaneous injection of CU-20401

High Dose Group

EXPERIMENTAL

0.08 /ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation

Drug: Subcutaneous injection of CU-20401

Placebo group

PLACEBO COMPARATOR

0/ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation

Drug: Subcutaneous injection of CU-20401

Interventions

Subcutaneous injection of CU-20401 DRUG

Reconstitute the product with 0.9% sodium chloride solution for injection, respectively, before use, for a single subcutaneous injection in the submental fat area.

Also known as: cu-20401

High Dose Group; Low Dose Group; Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the study contents, study process and possible adverse reactions, be able to complete the study in accordance with the protocol requirements, have reasonable expectations for the injection effect, and voluntarily sign the informed consent form;
• Men or women aged 18 to 65 years (including boundary values) at the time of signing the ICF;
• Body mass index (BMI) between 17 and 40 (kg/m2) at screening and baseline (including cut-off);
• At screening and baseline, the investigator rated moderate to severe submental outline protrusion due to submental fat accumulation according to the clinician-reported Submental Fat Rating Scale (CR-SMFRS) , i.e., those with a score of 2 to 3 points; and the subject-reported Submental Fat Rating Scale (PR-SMFRS)rated the amount of submental fat as moderate/large/very large, i.e., those with a score of 2 to 4;
• Subjects of childbearing potential (including males and females) have no pregnancy plans and voluntarily take effective contraceptive measures at screening and throughout the trial, and have no sperm or egg donation plans.

You may not qualify if:

• Subjects who have received prior surgery, liposuction therapy, or injection of lipolytic drugs similar to the investigational drug (e.g., phosphatidylcholine, etc.) at the submental site;
• Those who have received biomaterial fillings (e.g., hyaluronic acid, collagen, etc.) within 24 months prior to screening and at the neck or submental site before baseline;
• Those who have received botulinum toxin injection within 3 months prior to screening and at the neck or submental site prior to baseline, or have received noninvasive skin tightening therapy;
• Planned to undergo cosmetic procedures at the submental site during the study, including, but not limited to, dermal filling, surgical wrinkle removal, photoelectric therapy, water light needles, microneedles, chemical exfoliation, or scar removal surgery, etc.;
• Enlargement of the submental area due to other causes of excess non-submental fat accumulation (e.g., goiter, lymphadenopathy, Madelong's disease, platysma protrusion at rest, etc.) or affect the investigator's assessment of submental fat;
• Those with obvious scars, infections, cancerous or precancerous lesions and/or unresolved wounds, retrognathia, etc. in the chin and neck position, which may affect the evaluation results as assessed by the investigator;
• According to the investigator's judgment, submental fat dissolution can cause submental skin relaxation (SMSLG) to be Grade 4 or have other anatomic features (e.g., bulging fat under the platysma, extreme skin relaxation of the neck or submental area, protrusion of the platysma band), resulting in unacceptable cosmetic results;
• Subjects with a pre-existing tendency to scar hyperplasia or keloid may affect the efficacy assessment or subject safety after treatment as judged by the investigator;
• Subjects with symptoms or associated diseases of dysphagia at screening and baseline;
• Abnormal clinical laboratory tests (AST or ALT values above twice the upper limit of normal; serum creatinine above 1.5 times the upper limit of normal; triglycerides above 2 times the upper limit of normal) at screening and baseline; or other laboratory tests, vital signs, physical examination, electrocardiogram test results are abnormal and clinically significant, and the investigator considers it inappropriate to participate in this study;
• Other acute or chronic diseases (including but not limited to cardiovascular and cerebrovascular, respiratory, endocrine, digestive, renal, liver, blood and lymphatic, immune, metabolic and skeletal, central nervous system or psychiatric disorders, etc.) at screening and baseline, which, as judged by the investigator, may increase the risk associated with the use of the investigational product, or may affect the interpretation of the study results, or fail to cooperate well with the study participant;
• Hepatitis B surface antigen (HBsAg) positive, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, treponema pallidum antibody (TP-Ab) test positive at screening;
• Clotting test results (prothrombin time, activated partial thromboplastin time) within 4 weeks prior to dosing indicate any clinically significant bleeding tendency (patients receiving antiplatelet, anticoagulant, acetylsalicylic acid therapy may be enrolled after a 7-day washout period);
• Those who have used topical medications (e.g., glucocorticoids, tretinoin ointment) within 4 weeks prior to screening and in the prebaseline submental area, or are expected to require use in the submental area during the course of the study (up to 12 weeks after completion of injection);
• Plan any surgery during the trial that may result in significant weight change (≥ 10%) or take any medication that may result in significant weight change (≥ 10%) (e.g. systemic corticosteroids, bariatric medications, bariatric surgery);

Sponsors & Collaborators

• Cutia Therapeutics（Wuxi）Co.,Ltd: lead

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Study Officials

• byron Zhu, MD

  CMO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 8, 2024
• Study Start: December 20, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)