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.

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called GS1-144, which comes in tablet form, for women who are experiencing moderate to severe vasomotor symptoms (VMS) related to menopause. VMS can include hot flashes and night sweats, which can significantly affect daily life. The study aims to see how effective and safe GS1-144 is for Chinese postmenopausal women who have been struggling with these symptoms.

To participate in the trial, women need to be between 18.5 and 30 kg/m² in body mass index (BMI), and they must have been menopausal for at least 12 months, or meet other specific criteria related to menopause. They should be experiencing an average of 7 or more episodes of VMS symptoms daily over the week before joining the study. Participants will be randomly assigned to receive either the GS1-144 treatment or a placebo (a non-active pill) without knowing which one they are taking. Throughout the study, their health will be monitored to ensure safety and to gather information about the treatment's effects. If you or someone you know is dealing with these symptoms, this trial might be an option to consider, but it's important to discuss eligibility with a healthcare provider.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • BMI is 18.5 to 30 kg/㎡(inclusive);
• • Females meeting 1 of the following criteria of menopause at screening visit: spontaneous amenorrhea for ≥ 12 consecutive months, spontaneous amenorrhea for ≥ 6 consecutive months with serum follicle-stimulating hormone (FSH) \> 40 IU/L, or 6 weeks past a postsurgical bilateral oophorectomy with or without hysterectomy;
• • Participants who are seeking treatment or relief for VMS and meet the criteria for moderate to severe VMS symptoms: during the 7 consecutive days prior to randomization, participants must have a minimum average of 7 episodes of moderate to severe VMS symptoms per day;
• • For females with uterus: endometrial thickness ≤ 4mm as shown by TVU at screening, or \> 4mm without atypical hyperplasia or carcinogenesis of the endometrium from the subsequent biopsy results (If the biopsy sample is insufficient or can't be obtained, it is considered normal and meets this inclusion criterion);
• • Volunteered to sign ICF and be able to understand and comply with the requirements of this study.
• 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.