Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women.

Phase 2

Recruiting

• Conditions: Vasomotor Syndrome
• Interventions: Drug: GS1-144; Drug: Placebo

• Registration Number: NCT06726850
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women.

Detailed Description

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women.

Study Timeline

• Study Start: 2022-09-02
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-01-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 129

Inclusion Criteria

Not provided

Exclusion Criteria

• Diseases or dysfunctions known to interfere with the clinical trial, including but not limited to: neuropsychiatric, cardiovascular, urological, digestive, respiratory,musculoskeletal, metabolic, endocrine, haematological, immune, dermatological and oncological conditions, etc., or poorly controlled chronic diseases with clinical significance;
• Thyroid or parathyroid-related hormones abnormalites with clinical significance at screening or baseline;
• Confirmed moderate to severe liver fatty at screening or baseline;
• Any surgical or medical conditions that may significantly affect the absorption, distribution, metabolism, and/or excretion of the drug, such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction, or dysuria;
• Current or prior history of malignancy (except for malignancies and basal cell carcinoma that have not received any antineoplastic treatment within 5 years prior to screening visit, or have currently recovered or have no risk of relapse during this study as assessed by the investigator);
• Abnormal uterine bleeding with clinical significance during screening period or baseline period;
• Participants who have attempted suicide within the last 1 year or are currently at risk of impulsive behavior or suicide;
• Participants with a history of severe allergy to investigational products or any of their excipients or with allergic constitution (e.g., being allergic to two or more drugs or foods);
• Participants who have positive serology results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) or syphilis;Abnormalities in vital signs during the screening period or baseline period, e.g., resting pulse rate < 55/min or > 105/min; systolic blood pressure < 90 mmHg or ≥ 160 mmHg; diastolic blood pressure < 60 mmHg or ≥ 100 mmHg, that upon evaluation by the investigator may interfere with this clinical study;
• BI-RADS (Breast Imaging Reporting and Data System) Category ≥4 on breast ultrasound within 6 months prior to randomization;
• Participants who have positive pregnancy test during screening or baseline period.
• 12-lead electrocardiography (ECG) abnormalities during screening period or baseline period, e.g., heart rate-corrected QT interval QTcF absolute value >470 ms (Fridericia's formula: QTcF=QT/RR0.33) that upon evaluation by the investigator may interfere with this clinical study;
• Abnormalities in laboratory tests during screening period or baseline period, e.g., alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2×upper limit of normal (ULN), or total bilirubin (TBIL) >1.5×ULN, that upon evaluation by the investigator may interfere with this clinical study;
• Creatinine >1.5×ULN or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 based on modification of diet in renal disease (MDRD) during screening period or baseline period;
• The participant has used or is using prohibited medications/therapies (moderate or strong CYP1A2 inhibitors, hormone replacement therapy or any VMS therapeutic agents [prescription, non-prescription or herbal medicines]) at screening and is unwilling to discontinue and wash out such medications throughout the study (see Section 6.9 for the washout intervals for prohibited concomitant medications and prior medications);
• Having participated in any other clinical trial within 3 months or any clinical study of fezolinetant or other treatments for VMS (except for participants who have not received any investigational product) within 1 year prior to screening, or planning to participate in any other clinical trial;
• Current or prior history of drug use, drug abuse or alcohol abuse;
• Any other conditions that are unsuitable for participating in this study in the opinion of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GS1-144 tablet	GS1-144	Participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks.
placebo	Placebo	Participants will receive multiple doses of placebo matching GS1-144 tablet for 12 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Changes from baseline in the frequency of moderate to severe VMS at Week 4.	Week 4	VMS symptom electronic log. Patient's overall impression of change scale(PGI-C). A scale of a patient's overall impression of severity(PGI-S).Perimenopausal specific Quality of Life scale(MENQOL). Modified Kupperman scale.
Changes from baseline in the frequency of moderate to severe VMS at Week 12	Week 12	VMS symptom electronic log. Patient's overall impression of change scale(PGI-C). A scale of a patient's overall impression of severity(PGI-S).Perimenopausal specific Quality of Life scale(MENQOL). Modified Kupperman scale.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in the severity of moderate to severe VMS at Week 4	Week 4	VMS symptom electronic log. Patient's overall impression of change scale(PGI-C). A scale of a patient's overall impression of severity(PGI-S).Perimenopausal specific Quality of Life scale(MENQOL). Modified Kupperman scale.
Changes from baseline in the severity of moderate to severe VMS at Week 12	Week 12	VMS symptom electronic log. Patient's overall impression of change scale(PGI-C). A scale of a patient's overall impression of severity(PGI-S).Perimenopausal specific Quality of Life scale(MENQOL). Modified Kupperman scale.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China