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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dicot AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

7 Nov 2024 → 19 Aug 2025

Decision date (initial)

2024-10-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Pharmacodynamic

To evaluate the efficacy of LIB-01 in the treatment of erectile dysfunction (ED).
Safety objective: To evaluate the safety of LIB-01.

Secondary objectives 5

1. To evaluate the efficacy of LIB-01 in improving EF (ability to penetrate) during sexual intercourse.
2. To evaluate the efficacy of LIB-01 in improving EF (maintained for completion) during sexual intercourse.
3. To evaluate the efficacy of LIB-01 in improving erections.
4. To evaluate the efficacy of LIB-01 in the treatment of ED.
5. To assess the pharmacokinetics (PK) of LIB-01 in participants with ED.

Conditions and MedDRA coding

Erectile dysfunction (ED)

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Swedish Medical Products Agency

Plan to share IPD

Yes

IPD plan description

The results from this trial may be submitted for publication in e.g., scientific journals or as abstracts for scientific conferences at the discretion of the Sponsor.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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

Exclusion criteria 31

1. 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.
2. Type 1 diabetes.
3. Haemoglobin A1c (HbA1c) ≥48 mmol/L (6.5%).
4. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
5. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
6. Any planned major surgery within the duration of the trial.
7. 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.
8. History of priapism, or increased risk due to underlying illness, including but not limited to hemoglobinopathies such as sickle cell anaemia or thalassemia.
9. History of glaucoma.
10. History of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).
11. History of prostatectomy.
12. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
13. Presence or history of drug abuse, as judged by the Investigator.
14. History of, or current use of anabolic steroids, as judged by the Investigator.
15. Bleeding deficiencies or ongoing anticoagulant therapy that would put the participant at risk, as judged by the investigator.
16. Uncontrolled cardiac disease within 6 months of screening, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident.
17. Use of nitrate medications within 14 days prior to the screening visit.
18. 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).
19. 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.
20. Primary hypoactive sexual desire.
21. 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.
22. Insufficient therapeutic effect when using PDE5-Is.
23. History of, or ongoing antiandrogen treatment.
24. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B and C antibodies and/or human immunodeficiency virus (HIV).
25. Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the Investigator.
26. Moderate to severe renal impairment with an eGFR (creatinine) ≤60 mL/min (revised Malmö-Lund equation).
27. Moderate to severe hepatic impairment at the time of the screening visit, as judged by the Investigator.
28. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the last three months prior to the screening visit.
29. Planned treatment or treatment with another investigational therapy (i.e., small molecule or biologic) within 3 months prior to the screening visit.
30. Involvement in the planning, and/or conduct of the trial.
31. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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. Safety endpoint: Frequency, seriousness and intensity of adverse events (AEs), Clinically significant changes in safety laboratory measurements, vital signs and electrocardiogram (ECG).

Secondary endpoints 6

1. Percentage of successful attempts by the Sexual Encounter Profile (SEP) question 2 throughout the trial period.
2. Percentage of successful attempts by the SEP question 3 throughout the trial period.
3. Percentage of improved erections by the Global Assessment Question (GAQ) at week 4 and week 8.
4. IIEF-EF domain responder rate by minimally clinically important difference (MCID) at week 4 and week 8.
5. Change from baseline in sub-domain scores (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) of the patient questionnaire IIEF at week 4 and week 8.
6. PK parameters of LIB-01 in plasma.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dicot AB

Sponsor organisation

Dicot AB

Address

S:t Olofsgatan 11a, Uppsala Domkyrkofors Uppsala Domkyrkofors

City

Uppsala

Postcode

753 21

Country

Sweden

Scientific contact point

Organisation

Dicot AB

Contact name

Charlotta Gauffin

Public contact point

Organisation

Dicot AB

Contact name

Elin Trampe

Third parties 1

Locations

3 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications