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

NCT06703840 | Completed Phase 2

• 1 other identifier: DCT4564
• Study Type: interventional
• Target: 156
• Locations: 3 countries
• Sites: 6

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (13)

• To evaluate the efficacy of LIB-01 in improving erectile function (ability to penetrate) during sexual intercourse.

  8 weeks

• To evaluate the efficacy of LIB-01 in improving erectile function (maintained for completion) during sexual intercourse.

  8 weeks

• To evaluate the efficacy of LIB-01 in improving erections.

  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

  8 weeks

• To evaluate changes in vital signs (blood pressure), following oral dosing of LIB-01.

  8 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

LIB-01 Placebo, oral suspension

Drug: LIB-01 Placebo

LIB-01 10 mg

EXPERIMENTAL

LIB-01 10 mg, oral suspension

Drug: LIB-01

LIB-01 25 mg

EXPERIMENTAL

LIB-01 25 mg, oral suspension

Drug: LIB-01

LIB-01 50 mg

EXPERIMENTAL

LIB-01 50 mg, oral suspension

Drug: LIB-01

Interventions

LIB-01 DRUG

LIB-01 oral suspension

LIB-01 10 mg; LIB-01 25 mg; LIB-01 50 mg

LIB-01 Placebo DRUG

LIB-01 Placebo oral suspension

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dicot AB: lead

Study Sites (6)

Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

Clinical Trial Consultants

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Clinical Trial Consultants

Mölndal, Göteborg, 431 53, Sweden

Location

Clinical Trial Consultants

Linköping, Linköping, 582 13, Sweden

Location

Clinical Trial Consultants

Solna, Stockholm County, 171 64, Sweden

Location

Clinical Trial Consultants

Uppsala, Uppsala County, 75237, Sweden

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: November 8, 2024
• Primary Completion: July 19, 2025
• Study Completion: August 19, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); DK (1); SE (4)