Atherosclerotic Cardiovascular Disease (ASCVD)Phase 2NCT07311330
Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction
A Phase 2 study testing YN001 20mg Dose + 5% glucose injection and 5% glucose injection in people with Atherosclerotic Cardiovascular Disease (ASCVD) and Erectile Dysfunction, run by Beijing Inno Medicine Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD), Erectile Dysfunction
- What is being tested?
- YN001 20mg Dose + 5% glucose injection and 5% glucose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- 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.);
- Presenting with hypothyroidism, defined as marked TSH elevations (usually > 1.5 ULN) associated with decreases in free T4 (FT4) ;
- Patients with a history of drug abuse, drug abuse and alcoholism (tolerance, withdrawal, impaired control of drinking behavior) in the past 1 year;
- Participation in another interventional clinical investigator within 1 month prior to informed consent;
- Patients who, in the opinion of the investigator, are not suitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Jilin, 130021
Long Tian, +86-18612311999, longtian@ccmu.edu.cn
About this study
Official title: 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
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
- Being tested
- YN001 20mg Dose + 5% glucose injection, 5% glucose injection
- Medical subject headings
- Atherosclerosis, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YN001 20mg Dose + 5% glucose injectionDrug
The treamtment group was given YN001 20 mg, once a week (QW), cumulative administration for 12 weeks (about 3 months)
5% glucose injectionOther
The control group was given placebo once a week (QW), cumulative administration for 12 weeks (about 3 months)
| Study group | Role | What they receive |
|---|---|---|
| YN001 20mg Dose + 5% glucose injection | Active comparator | Specified dose on specified Days Receives: Drug: YN001 20mg Dose + 5% glucose injection |
| 5% glucose injection | Placebo comparator | Specified dose on specified Days Receives: Other: 5% glucose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in IIEF-EF (Questions 1-5 and 15 in the IIEF scale) score at Week 13 visit;
Measured: 12 weeks
Change From Baseline in Carotid Artery Intima-media Thickness (IMT) by Peripheral Ultrasound at Week 13 Visit.
Measured: 12 weeks
Secondary outcomes (1)
Adverse event (AE)/serious adverse event (SAE);
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start4 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311330
- Sponsor's protocol ID
- YN001-006
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07311330
- Acronym / sponsor ID
- YN001-006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YN001 20mg Dose + 5% glucose injection | Active comparator | Drug: YN001 20mg Dose + 5% glucose injectionSpecified dose on specified Days |
| 5% glucose injection | Placebo comparator | Other: 5% glucose injectionSpecified dose on specified Days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YN001 20mg Dose + 5% glucose injectionThe treamtment group was given YN001 20 mg, once a week (QW), cumulative administration for 12 weeks (about 3 months) | Drug | YN001 20mg Dose + 5% glucose injection |
| 5% glucose injectionThe control group was given placebo once a week (QW), cumulative administration for 12 weeks (about 3 months) | Other | 5% glucose injection |
Primary outcome
Change from baseline in IIEF-EF (Questions 1-5 and 15 in the IIEF scale) score at Week 13 visit;
Time frame: 12 weeks
Change From Baseline in Carotid Artery Intima-media Thickness (IMT) by Peripheral Ultrasound at Week 13 Visit.
Time frame: 12 weeks
1 secondary outcome
Adverse event (AE)/serious adverse event (SAE);
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YN001 20mg Dose + 5% glucose injection and 5% glucose injection in people with Atherosclerotic Cardiovascular Disease (ASCVD) and Erectile Dysfunction, run by Beijing Inno Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Zhang (861082599080, zhangjing@innovmedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in IIEF-EF (Questions 1-5 and 15 in the IIEF scale) score at Week 13 visit; (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.