Evaluation of LIB-01 Monohydrate for Safety and Efficacy in Erectile Dysfunction: A Phase 2a Randomized, Double-Blind, Placebo-Controlled Trial
- Trial ID
- 2024-515065-34-00
- Protocol
- DCT4564
- Sponsor
- Dicot AB
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this Phase 2a, randomized, double-blind, parallel, and placebo-controlled trial is to evaluate the **efficacy** of LIB-01 in the treatment of **erectile dysfunction (ED)**. This is clinically relevant as ED is a common condition that can significantly impact quality of life and psychological well-being. Additionally, the trial aims to assess the safety of LIB-01, ensuring that the treatment is not only effective but also safe for patient use.
Secondary objectives include:
- Evaluating the efficacy of LIB-01 in improving erectile function (EF) specifically in terms of the ability to penetrate during sexual intercourse.
- Assessing the efficacy of LIB-01 in maintaining EF for the completion of sexual intercourse.
- Investigating the overall improvement in erections with LIB-01.
- Evaluating the efficacy of LIB-01 in the broader treatment of ED.
- Assessing the pharmacokinetics (PK) of LIB-01 in participants with ED, which is crucial for understanding the drug's absorption, distribution, metabolism, and excretion.
Participants
The clinical trial focuses on evaluating the efficacy and safety of LIB-01 in the treatment of **erectile dysfunction (ED)**. The study population comprises male participants aged between 25 to 65 years, who are in a stable heterosexual relationship for at least six months prior to the screening visit. Participants are required to have a total score of 11-25 on specific questions of the International Index of Erectile Function (IIEF) questionnaire, indicating a certain level of erectile dysfunction. The trial does not include female subjects and does not target a vulnerable population. Participants are expected to adhere to specific lifestyle considerations, such as abstaining from unprotected sex and using condoms to prevent drug exposure to partners, as well as refraining from donating sperm during and after the trial period. The sponsor has not provided information regarding the total number of participants in the study.
Plans and Procedures
The clinical trial is a **randomized**, **double-blind**, parallel, and placebo-controlled study designed to evaluate the safety and efficacy of **LIB-01** in the treatment of **erectile dysfunction**. The trial is set to commence on October 28, 2024, with an estimated completion date of May 26, 2025. Participants will be randomly assigned to receive either the investigational product, **LIB-01**, or a placebo, both administered as a **powder for oral suspension**. The trial will involve a maximum daily dose of 50 mg, 25 mg, or 10 mg of LIB-01, with a total dose not exceeding 150 mg, 75 mg, or 30 mg, respectively, over a treatment period of up to 3 weeks.
The study will include several visits, beginning with a screening visit to confirm eligibility based on criteria such as age, relationship status, and motivation to treat **erectile dysfunction**. Participants must provide informed consent and meet specific inclusion criteria, including a stable heterosexual relationship and a defined score on the International Index of Erectile Function (IIEF) questionnaire. The primary endpoint is the change from baseline in the erectile function domain of the IIEF at week 4, with safety endpoints including the frequency and intensity of adverse events, and changes in laboratory measurements, vital signs, and ECG.
Follow-up visits will occur throughout the trial period to monitor efficacy and safety, with assessments including the percentage of successful attempts by the Sexual Encounter Profile (SEP) questions and changes in sub-domain scores of the IIEF. The end-of-study visit will conclude the trial, assessing the overall outcomes and any long-term effects. Participant involvement is expected to last until the end-of-study visit, with conditions for early termination including withdrawal of consent or significant adverse events. The trial aims to provide comprehensive data on the efficacy and safety of LIB-01 for **erectile dysfunction**, contributing valuable insights into its potential therapeutic benefits.
Treatment
The clinical trial involves the administration of **LIB-01 MONOHYDRATE**, a semi-synthetic medicinal product, formulated as a **powder for oral suspension**. The active substance, LIB-01 MONOHYDRATE, is of chemical origin and is provided by DICOT AB. The trial includes three different dosing regimens of LIB-01 MONOHYDRATE. The first regimen involves a maximum daily dose of 50 mg, with a total maximum dose of 150 mg over a treatment period of 3 days. The second regimen allows for a maximum daily dose of 10 mg, with a total maximum dose of 30 mg over the same treatment period. The third regimen permits a maximum daily dose of 25 mg, with a total maximum dose of 75 mg, also over 3 days. All doses are administered orally.
In addition to the experimental medication, a **placebo** is used as a comparator in this double-blind, placebo-controlled trial. The placebo is formulated as a powder for suspension, utilizing the vehicle SyrSpend® SF PH4. The placebo is designed to match the experimental product in appearance and administration route to maintain blinding. The placebo does not contain the active substance and serves to evaluate the efficacy and safety of LIB-01 MONOHYDRATE by comparison.
Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen. The trial aims to assess the efficacy of LIB-01 in the treatment of erectile dysfunction, while also evaluating the safety profile of the medication. The trial is conducted under strict regulatory standards, with all products having received the necessary authorization for use in the study.
Efficacy
The efficacy of LIB-01 in the treatment of **erectile dysfunction** will be assessed using several parameters. The primary endpoint is the change from baseline in the total score on the erectile function (EF) domain of the International Index of Erectile Function (IIEF-EF) questionnaire at week 4. This validated scale will be used to measure improvements in erectile function. Secondary endpoints include the percentage of successful attempts as measured by the Sexual Encounter Profile (SEP) questions 2 and 3 throughout the trial period, and the percentage of improved erections as assessed by the Global Assessment Question (GAQ) at weeks 4 and 8. Additionally, the IIEF-EF domain responder rate by minimally clinically important difference (MCID) will be evaluated at weeks 4 and 8, along with changes from baseline in sub-domain scores (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) of the IIEF questionnaire at the same time points. Pharmacokinetic (PK) parameters of LIB-01 in plasma will also be analyzed.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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, or willing to use condom to prevent drug exposure of a partner from first dose of IMP to 24 hours after the last dose. 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. Participants in the Netherlands: 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.
Exclusion Criteria
- 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.
- 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 Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Not Recruiting | 28 Oct 2024 | 20 |
 The Netherlands | Not Recruiting | 28 Oct 2024 | — |
 Sweden | Not Recruiting | 28 Oct 2024 | 100 |
| Netherlands | — | — | 20 |
Sites & Investigators
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
LIB-01 MONOHYDRATE | Test | POWDER FOR ORAL SUSPENSION | ORAL USE | 50 | 3 | PRD11379660 |
LIB-01 MONOHYDRATE | Test | POWDER FOR ORAL SUSPENSION | ORAL USE | 10 | 3 | PRD11379613 |
LIB-01-placebo powder for suspension
Vehicle: SyrSpend® SF PH4 | Placebo | N/A | — | — | — | N/A |