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Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction

A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction

NCT07311330•Beijing Inno Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of YN001 in patients with atherosclerotic cardiovascular and cerebrovascular diseases and erectile dysfunction

Eligibility

Age

18 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Fully understand the purpose, nature, method and possible adverse reactions of the study, voluntarily participate as a subject in the study, and sign the informed consent form (ICF) before performing any study-related assessments;
•2. One or both of the previous history of coronary atherosclerosis, coronary heart disease, cerebral atherosclerosis, stroke, ischemic attack, carotid atherosclerosis, peripheral arterial disease, or plaque in at least one vessel of the carotid, subclavian, or femoral arteries as detected by peripheral arterial ultrasound .
•3. Clinical diagnosis of mild to moderate erectile dysfunction, IIEF-5 questionnaire score ≤ 21 points, duration of at least 3 months (subject to signing informed consent);
•4. Subjects (including partners) guarantee that they have no plans to father a child or donate sperm during the study and for 3 months after the last dose and voluntarily take appropriate contraceptive measures;
•5. After the screening run-in period, the following three conditions were met simultaneously:
•1\) At least 4 attempts at sexual intercourse during the run-in period; 2) Has a failure rate of ≥ 50% of attempts to intercourse (failure to intercourse is defined as having at least one of the three questions answered on the SEP); 3) IIEF-EF score ≥ 11 and ≤ 25.

Exclusion Criteria

•1. Patients with erectile dysfunction caused by other sexual dysfunction diseases (such as ejaculatory dysfunction) or endocrine diseases that are not controlled (after medication) (such as hypogonadism, hyperthyroidism/hypothyroidism, pituitary tumor, etc.);
•2. History of stroke within 6 months prior to informed consent;
•3. Patients who have received or are receiving anti-androgen therapy, or have a history of androgen replacement therapy and are stable for less than 3 months;
•4. Patients scheduled for CABG, PCI, heart transplantation, SAVR/TAVR during the study period;
•5. Patients with unstable diabetic blood glucose control, and fasting blood glucose more than 15 mmol/L, or accompanied by diabetic complications (diabetic nephropathy, peripheral neuropathy);
•6. Combined with abnormal liver function, defined as AST and/or ALT more than 2 times the upper limit of normal;
•7. Combined with severe renal dysfunction, defined as glomerular filtration rate \< 30.0 mL/min/1.73m ² calculated by CKD-EPI formula;
•8. Subjects who have used vacuum aspiration (VCD), intracavernosal injection (ICI) therapy or other drugs to treat erectile dysfunction and cannot interrupt the above treatment during the study;
•9. Patients who have severe central nervous system injury (cerebral vascular diseases such as cerebral hemorrhage or ischemia, brain inflammatory diseases such as encephalitis or meningitis, craniocerebral trauma or spinal cord injury), or peripheral nervous system injury or lesions within 6 months before signing the informed consent;
•10. History of myopathy/myalgia, or susceptibility to myopathy/rhabdomyolysis (e.g., family history of hereditary myopathy, previous use of HMG-CoA reductase inhibitors in combination with fibrates, etc.);
+4 more criteria

Key Dates

Start Date

January 31, 2026

Primary Completion Date

June 16, 2026

Completion Date

November 14, 2026

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)Erectile Dysfunction

Interventions

YN001 20mg Dose + 5% glucose injection

DRUG

5% glucose injection

OTHER

Contacts

Jean Zhang

CONTACT

861082599080 zhangjing@innovmedicine.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction

Inclusion Criteria

Exclusion Criteria

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