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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

Short name LASARE

Overview

Status
Completed
Phase
Phase 1
Enrollment
34 participants (actual)
Sponsor
4Moving Biotech · Industry
Design
Randomized · Double masking
Countries
1 country

Belgium

Start
9 Aug 2022
Primary completion
31 Oct 2023
Completion
31 Oct 2023
First posted
15 Jun 2022
Last update posted
26 Jun 2025
Conditions
Knee Osteoarthritis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 1

    LASARE

    NCT05419856

    9 Aug 2022 to 31 Oct 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • 4P-004Drug
  • PlaceboDrug

Arms5

  • Experimental

    4P-004 w mg

    4P-004 is administered once intraarticularly in the target knee joint Dose = w mg

  • Experimental

    4P-004 x mg

    4P-004 is administered once intraarticularly in the target knee joint Dose = x mg

  • Experimental

    4P-004 y mg

    4P-004 is administered once intraarticularly in the target knee joint Dose = y mg

  • Experimental

    4P-004 z mg

    4P-004 is administered once intraarticularly in the target knee joint Dose = z mg

  • Placebo comparator

    Placebo

    Placebo is administered once intraarticularly in the target knee joint

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Day 1-Day 28

    Registry description

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

Secondary outcomes(1)
  1. 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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 1-Day 28

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

GroupValue (participants)
4P-004 w mg5
4P-004 x mg5
4P-004 y mg5
4P-004 z mg6
Placebo6
Secondary and other outcome results(2)
Secondary outcomeMean· Day 1 to Day 2

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

GroupValue (ng/mL)Spread
4P-004 w mg00
4P-004 x mg00
4P-004 y mg00
4P-004 z mg00
Placebonot posted–
Other pre specified outcome· Day 1, Day 2, Day 8

Exploratory Biomarkers Identification

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
4P-004 w mg4P-004: single intraarticular administration in the knee joint Dose = w mg0 / 60 / 65 / 6
4P-004 x mg4P-004: single intraarticular administration in the knee joint Dose = x mg0 / 60 / 65 / 6
4P-004 y mg4P-004: single intraarticular administration in the knee joint Dose = y mg0 / 61 / 65 / 6
4P-004 z mg4P-004: single intraarticular administration in the knee joint Dose = z mg0 / 80 / 86 / 8
PlaceboPlacebo: single intraarticular administration in the knee joint0 / 80 / 86 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Animal study · 2022

Liraglutide, a glucagon-like peptide 1 receptor agonist, exerts analgesic, anti-inflammatory and anti-degradative actions in osteoarthritis.

Meurot et al. 2022Scientific reportscited by 131

PMID 35091584PMC8799666DOI 10.1038/s41598-022-05323-7PUB-35091584

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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