Not Yet RecruitingPhase 2

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

40 participantsStarted 2026-01-31

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexMALE

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Inclusion criteria

✓. 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;
✓. 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 .
✓. 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);
✓. 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;
✓. After the screening run-in period, the following three conditions were met simultaneously:

Exclusion criteria

✕. 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.);
✕. History of stroke within 6 months prior to informed consent;
✕. 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;
✕. Patients scheduled for CABG, PCI, heart transplantation, SAVR/TAVR during the study period;
✕. 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);
✕. Combined with abnormal liver function, defined as AST and/or ALT more than 2 times the upper limit of normal;
✕. Combined with severe renal dysfunction, defined as glomerular filtration rate \< 30.0 mL/min/1.73m ² calculated by CKD-EPI formula;
✕. 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;

What they're measuring

Change from baseline in IIEF-EF (Questions 1-5 and 15 in the IIEF scale) score at Week 13 visit;

Timeframe: 12 weeks

Change From Baseline in Carotid Artery Intima-media Thickness (IMT) by Peripheral Ultrasound at Week 13 Visit.

Timeframe: 12 weeks

Trial details

NCT IDNCT07311330

SponsorBeijing Inno Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-16

Contact for this trial

Jean Zhang

861082599080 zhangjing@innovmedicine.com

View on ClinicalTrials.gov More Atherosclerotic Cardiovascular Disease (ASCVD) trials