Current partner codePEPTIDESDE
NCT05419856·Phase 1·INTERVENTIONAL

Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL 2-4 Osteoarthritic Knee

Status

Completed

Phase

Phase 1

Enrollment

34

Locations

3

Results

Posted

Publications

1

Study summary

What the protocol is testing.

This phase I study is a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending dose of IA 4P-004 in participants, * Between 18 and 80 years of age, * with target knee OA stage KL 2-4 A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).

Interventions

Treatment arms and agents.

DRUG

4P-004

single intraarticular administration in the knee joint

DRUG

Placebo

single intraarticular administration in the knee joint

Timeline

From registration to results.

  1. First posted

    Jun 15, 2022

  2. Study start

    Aug 9, 2022

  3. Primary completion

    Oct 31, 2023

  4. Study completion

    Oct 31, 2023

  5. Results posted

    May 15, 2025

  6. Registry updated

    Jun 26, 2025

Outcomes

What the study measures.

Primary outcomes

Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.

Time frame · Day 1-Day 28

Number of participants with Adverse Events, serious AEs (SAEs), with abnormal Vital signs, abnormal ECG reading and abnormal Laboratory test results

Secondary outcomes

To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA

Time frame · Day 1 to Day 2

Plasma concentration of liraglutide following a single IA injection at pre-injection (Time \[-4hours-0\]) and 2hours, 4hours, 8hours, 12hours, 16hours and 24-hours post injection.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Participants who have the capacity to give informed consent and who are willing to comply with all study related procedures and assessments (consent via legally authorized representative will not be accepted), * Ambulatory participants, agreeing a 24-hour hospitalization, * Participants between 18 and 80 years of age, * Female participant of childbearing potential (WOCBP), must use contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see section 11.4) for at least 5 days following IMP injection, and must have a negative urine pregnancy test done within 24h before randomization, * Male participants (whose partners are of childbearing potential) must consent to use methods of contraception consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see section 11.4), for at least 90 days following IMP injection, * Participants with knee osteoarthritis, KL 2-4 of their target knee (defined at screening as the knee with greater pain based on the participant's evaluation and the investigator's clinical judgment), * X-rays of the target knee within 6 months (if not, to be performed before randomization), * ECG within normal range, * WBC (white blood cell count) \> 3500/µL, * Hemoglobin \> 12 g/dL, * Platelets \> 100,000/ µL, * Creatinine clearance (CrCl) \> 60 mL/min, * Glycemia within normal range, * AST, ALT \< 1.5 upper limit of normal (ULN), * Amylasemia \< 1ULN, * Negative tests for COVID-19 (if required by the standard practice on site), HIV, HbsAg and hepatitis C Ab (Determination of HIV and hepatitis status can be based on participant-reported medical history, available medical records, and the most recently available laboratory results for the participant \[tests performed within the previous 12 months\]). Exclusion Criteria: * Breastfeeding women, * Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening, * Any treatment with glucosamine or chondroitin sulfate in the previous 3 months, * Any glucagon-like peptide 1 analogue hormones, * Anticoagulant treatment (current or within the last 10 days), * Treatment of the target knee with any IA injection (steroids, hyaluronic acid derivatives, PRP ….) within 3 months, * Knee surgery (of the target knee) performed within the previous 12 months or planned within the next 6 months, * Any partial knee replacement of the target knee, * Any known active infections or increased predisposition for the development of infections * Clinical signs and symptoms of active joint crystal disease, or any inflammatory joint disease, * Diabetes type I or II, * Congestive Heart Failure stage III or IV of NYHA classification, * Inflammatory bowel disease, * Any other chronic condition that has not been well controlled for a minimum of 3 months, * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer) within the last 5 years, * Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation, (for example, any abnormal reaction to previous IA injection), * Hypersensitivity to the active substance liraglutide or to any of the excipients: Disodium phosphate dihydrate, Propylene glycol, Phenol, * Participation in an interventional clinical research trial within 12 weeks prior.

Study locations

3 registered sites.

Belgium. Showing up to 24 locations stored in the fast local snapshot.

UCL-St Luc

Brussels, Belgium

AZMaria Middelares

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.