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

ConditionsAtherosclerotic Cardiovascular Disease (ASCVD)Erectile Dysfunction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-75
SponsorBeijing Inno Medicine Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • YN001 20mg Dose + 5% glucose injection

    Drug

    The treamtment group was given YN001 20 mg, once a week (QW), cumulative administration for 12 weeks (about 3 months)

  • 5% glucose injection

    Other intervention

    The control group was given placebo once a week (QW), cumulative administration for 12 weeks (about 3 months)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: YN001 20mg Dose + 5% glucose injectionActive comparator 1 intervention
Group B: 5% glucose injectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks
2

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

Time frame
12 weeks

Secondary outcomes

1

Adverse event (AE)/serious adverse event (SAE);

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Inno Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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