Phase 2a Trial to Investigate the Efficacy of LIB-01 in Treatment of Erectile Dysfunction

A Phase 2 study testing LIB-01 in people with Erectile Dysfunction, run by Dicot AB at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this clinical trial is to learn if the drug LIB-01 works to treat erectile dysfunction in male adults. It will also learn about the safety of the drug LIB-01. The main questions it aims to answer are: Does the drug LIB-01 improve erectile function in males with erectile dysfunction? What medical problems… Read more about this study

Who is it for?: Ages 25 to 65 years, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: LIB-01
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 6 sitesin 3 countries
Study dates: 8 Nov 2024to 19 Aug 2025
Phase: Phase 2
Are there results?: None posted in the registry

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 25 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed and dated written informed consent prior to any trial specific procedures.
Male participant aged 25 to 65 years, inclusive, at the screening visit.
In a stable heterosexual relationship for at least 6 months prior to the screening visit.
Total score of 11-25 on questions 1-5 and 15 on the EF domain of the IIEF questionnaire.
Highly motivated to obtain treatment for ED.
Willing to abstain from unprotected sex and use condom to prevent drug exposure of a partner and pregnancy from first dose until the end-of-trial. In addition, refrain from donating sperm from the date of dosing until 3 months after (last) dosing with the IMP. Any female partner of child-bearing potential of a non-vasectomised trial participant must use contraceptive methods with a failure rate of < 1% to prevent pregnancy until the end-of-trial visit.
Understands the trial requirements.

Who cannot join

History of any clinically significant disease or disorder, including psychiatric disorder, which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
Type 1 diabetes.
Haemoglobin A1c (HbA1c) ≥48 mmol/L (6.5%).
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
Any planned major surgery within the duration of the trial.

Show all 31Show fewer

History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to LIB-01 API.
History of priapism, or increased risk due to underlying illness, including but not limited to hemoglobinopathies such as sickle cell anaemia or thalassemia.
History of glaucoma.
History of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).
History of prostatectomy.
History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
Presence or history of drug abuse, as judged by the Investigator.
History of, or current use of anabolic steroids, as judged by the Investigator.
Bleeding deficiencies or ongoing anticoagulant therapy that would put the participant at risk, as judged by the investigator.
Uncontrolled cardiac disease within 6 months of screening, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident.
Use of nitrate medications within 14 days prior to the screening visit.
Use of any drug with narrow therapeutic index or drugs that are sensitive substrates, strong inducers or strong inhibitors to CYP3A4 as well as substrates and inhibitors of OATP1B1 or sensitive to substrates to CYP2B6 in accordance with the list provided (see Section 9.6.2.1).
Use of oral, injectable, intra-urethral, or topical pro-erectile drugs or supplements, including but not limited to PDE5-Is or prostaglandin E1, or use of devices for ED treatment, within 14 days prior to screening.
Primary hypoactive sexual desire.
Presence of penile anatomical abnormalities, such as penile fibrosis or Peyronie's disease, which would cause significantly impaired sexual performance, as judged by the Investigator.
Insufficient therapeutic effect when using PDE5-Is.
History of, or ongoing antiandrogen treatment.
Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B and C antibodies and/or human immunodeficiency virus (HIV).
Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the Investigator.
Moderate to severe renal impairment with an eGFR (creatinine) ≤60 mL/min (revised Malmö-Lund equation).
Moderate to severe hepatic impairment at the time of the screening visit, as judged by the Investigator.
Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the last three months prior to the screening visit.
Planned treatment or treatment with another investigational therapy (i.e., small molecule or biologic) within 3 months prior to the screening visit.
Involvement in the planning, and/or conduct of the trial.
The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

Sweden4 sites

Clinical Trial Consultants
Linköping, Linköping, 582 13
Clinical Trial Consultants
Mölndal, Göteborg, 431 53
Clinical Trial Consultants
Solna, Stockholm County, 171 64
Clinical Trial Consultants
Uppsala, Uppsala County, 75237

Other trials in Sweden

Denmark1 site

Herlev Hospital
Herlev, Herlev, 2730

Other trials in Denmark

Netherlands1 site

Clinical Trial Consultants
Groningen, Provincie Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: A Phase 2a, Randomised, Double-blind, Parallel and Placebo-controlled Trial Investigating Safety and Efficacy of LIB-01 in Treatment of Erectile Dysfunction

Does the drug LIB-01 improve erectile function in males with erectile dysfunction?
What medical problems do participants have when taking the drug LIB-01? Researchers will compare the drug LIB-01 to a placebo (a look-alike substance that contains no drug) to see if the drug LIB-01 works to treat erectile dysfunction.

Participants will:

Take the drug LIB-01 or a placebo every day for 3 days
Visit the clinic every week for 4 weeks, and at 8 weeks, for checkups and tests

Conditions: Erectile Dysfunction
Being tested: LIB-01, LIB-01 Placebo
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIB-01Drug
LIB-01 oral suspension
LIB-01 PlaceboDrug
LIB-01 Placebo oral suspension

Study groups in NCT06703840
Study group	Role	What they receive
Placebo	Placebo comparator	LIB-01 Placebo, oral suspension Receives: Drug: LIB-01 Placebo
LIB-01 10 mg	Experimental	LIB-01 10 mg, oral suspension Receives: Drug: LIB-01
LIB-01 25 mg	Experimental	LIB-01 25 mg, oral suspension Receives: Drug: LIB-01
LIB-01 50 mg	Experimental	LIB-01 50 mg, oral suspension Receives: Drug: LIB-01

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the efficacy of LIB-01 in the treatment of erectile dysfunction (ED).
Change from baseline in total score on the erectile function (EF) domain of the patient questionnaire International Index of Erectile Function (IIEF-EF) at week 4.
Measured: 4 weeks

Secondary outcomes (13)

To evaluate the efficacy of LIB-01 in improving erectile function (ability to penetrate) during sexual intercourse.
Percentage of successful attempts by the Sexual Encounter Profile (SEP) question 2 throughout the trial period.
Measured: 8 weeks
To evaluate the efficacy of LIB-01 in improving erectile function (maintained for completion) during sexual intercourse.
Percentage of successful attempts by the Sexual Encounter Profile (SEP) question 3 throughout the trial period.
Measured: 8 weeks
To evaluate the efficacy of LIB-01 in improving erections.
Percentage of improved erections by the Global Assessment Question (GAQ) at week 4 and week 8.
Measured: 8 weeks
To evaluate the incidence of treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) following oral dosing of LIB-01
Frequency, seriousness and intensity of adverse events (AEs). Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE):
Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL.
Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE.
Measured: 8 weeks
To evaluate changes in vital signs (blood pressure), following oral dosing of LIB-01.
Clinically significant changes in blood pressure.
Measured: 8 weeks
To evaluate changes in vital signs (pulse), following oral dosing of LIB-01.
Clinically significant changes in pulse.
Measured: 8 weeks
To evaluate changes in vital signs (respiratory rate), following oral dosing of LIB-01.
Clinically significant changes in respiratory rate.
Measured: 8 weeks
To evaluate changes in vital signs (body temperature), following oral dosing of LIB-01.
Clinically significant changes in vital body temperature.
Measured: 8 weeks
To evaluate changes in ECG parameters (resting heart rate [HR]), following oral dosing of LIB-01.
Clinically significant changes in resting heart rate (HR).
Measured: 8 weeks
To evaluate changes in ECG parameters (PQ/PR), following oral dosing of LIB-01.
Clinically significant changes in PQ/PR interval.
Measured: 8 weeks
To evaluate changes in ECG parameters (QRS), following oral dosing of LIB-01.
Clinically significant changes in QRS interval.
Measured: 8 weeks
To evaluate changes in ECG parameters (QT), following oral dosing of LIB-01.
Clinically significant changes in QT interval.
Measured: 8 weeks
To evaluate changes in ECG parameters (QTcF [corrected QT interval by Fredericia]), following oral dosing of LIB-01.
Clinically significant changes in QTcF interval.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 202419 Aug 2025

First posted25 Nov 2024
Study start8 Nov 2024
Primary completion19 Jul 2025
Study completion19 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Erectile DysfunctionStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06703840
Sponsor's protocol ID: DCT4564
Status last verified: Aug 2025
First submitted: 19 Nov 2024
Last updated: 24 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomised, Double-blind, Parallel and Placebo-controlled Trial Investigating Safety and Efficacy of LIB-01 in Treatment of Erectile Dysfunction
ClinicalTrials.gov ID: NCT06703840
Acronym / sponsor ID: DCT4564
Conditions: Erectile Dysfunction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: Dicot ABIndustry (pharma, biotech, devices)
Study start: 8 Nov 2024 (actual)
Primary completion: 19 Jul 2025 (actual)
Study completion: 19 Aug 2025 (actual)
First posted: 25 Nov 2024 (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.

Does the drug LIB-01 improve erectile function in males with erectile dysfunction?
What medical problems do participants have when taking the drug LIB-01? Researchers will compare the drug LIB-01 to a placebo (a look-alike substance that contains no drug) to see if the drug LIB-01 works to treat erectile dysfunction.

Participants will:

Take the drug LIB-01 or a placebo every day for 3 days
Visit the clinic every week for 4 weeks, and at 8 weeks, for checkups and tests

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: LIB-01 PlaceboLIB-01 Placebo, oral suspension
LIB-01 10 mg	Experimental	Drug: LIB-01LIB-01 10 mg, oral suspension
LIB-01 25 mg	Experimental	Drug: LIB-01LIB-01 25 mg, oral suspension
LIB-01 50 mg	Experimental	Drug: LIB-01LIB-01 50 mg, oral suspension

Who may qualify

Ages: 25 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provision of signed and dated written informed consent prior to any trial specific procedures.
Male participant aged 25 to 65 years, inclusive, at the screening visit.
In a stable heterosexual relationship for at least 6 months prior to the screening visit.
Total score of 11-25 on questions 1-5 and 15 on the EF domain of the IIEF questionnaire.
Highly motivated to obtain treatment for ED.

Key exclusion criteria (31 listed)

History of any clinically significant disease or disorder, including psychiatric disorder, which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
Type 1 diabetes.
Haemoglobin A1c (HbA1c) ≥48 mmol/L (6.5%).
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.

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
LIB-01LIB-01 oral suspension	Drug	LIB-01 10 mg, LIB-01 25 mg, LIB-01 50 mg
LIB-01 PlaceboLIB-01 Placebo oral suspension	Drug	Placebo

Primary outcome

To evaluate the efficacy of LIB-01 in the treatment of erectile dysfunction (ED).
Time frame: 4 weeks
Change from baseline in total score on the erectile function (EF) domain of the patient questionnaire International Index of Erectile Function (IIEF-EF) at week 4.

13 secondary outcomes

To evaluate the efficacy of LIB-01 in improving erectile function (ability to penetrate) during sexual intercourse.
Time frame: 8 weeks
To evaluate the efficacy of LIB-01 in improving erectile function (maintained for completion) during sexual intercourse.
Time frame: 8 weeks
To evaluate the efficacy of LIB-01 in improving erections.
Time frame: 8 weeks
To evaluate the incidence of treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) following oral dosing of LIB-01
Time frame: 8 weeks
To evaluate changes in vital signs (blood pressure), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in vital signs (pulse), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in vital signs (respiratory rate), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in vital signs (body temperature), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in ECG parameters (resting heart rate [HR]), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in ECG parameters (PQ/PR), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in ECG parameters (QRS), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in ECG parameters (QT), following oral dosing of LIB-01.
Time frame: 8 weeks
To evaluate changes in ECG parameters (QTcF [corrected QT interval by Fredericia]), following oral dosing of LIB-01.
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
Individual participant dataSharing planned: Yes

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Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LIB-01 in people with Erectile Dysfunction, run by Dicot AB at 6 sites in 3 countries.

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 7 inclusion and 31 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: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden, Denmark, Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of LIB-01 in the treatment of erectile dysfunction (ED). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06703840.

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 24 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.