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LASARE

CompletedPhase 1Results posted

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

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of 4P004 Versus Placebo Injected in the Target Knee of Patients With Grade 2 to 4 Osteoarthritis on the Kellgren and Lawrence Severity Index

Lead sponsor

4Moving Biotech

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Osteoarthritis

Key I/E criterion

—

Primary endpoints

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05419856

Org study ID4MB-LAS-P

Timeline

Milestones

Study first posted2022-06-15actual

Study start2022-08-09actual

Primary completion2023-10-31actual

Study completion2023-10-31actual

Results first posted2025-05-15actual

Last update posted2025-06-26actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Osteoarthritis

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

4 endpoints

Primary/registry result

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

Time frame:Day 1-Day 28

Treatment-emergent AEs (any)

descriptive

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

Group	Value (number), participants	95% CI
4P-004 w mgTEAE	5	—
SAE	0	—
Abnormal Vital Sign	0	—
Abnormal Laboratory Value	0	—
Abnormal ECG	0	—
4P-004 x mgTEAE	5	—
SAE	0	—
Abnormal Vital Sign	0	—
Abnormal Laboratory Value	0	—
Abnormal ECG	0	—
4P-004 y mgTEAE	5	—
SAE	1	—
Abnormal Vital Sign	0	—
Abnormal Laboratory Value	0	—
Abnormal ECG	0	—
4P-004 z mgTEAE	6	—
SAE	0	—
Abnormal Vital Sign	0	—
Abnormal Laboratory Value	0	—
Abnormal ECG	0	—
PlaceboTEAE	6	—
SAE	0	—
Abnormal Vital Sign	0	—
Abnormal Laboratory Value	0	—
Abnormal ECG	0	—

Primary/protocol endpoint

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

Time frame:Day 1-Day 28

Treatment-emergent AEs (any)

descriptive

Secondary/registry result

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 (steady state)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	95% CI
4P-004 w mgTime [-4hours-0]	0	—
Time 2 hours	3.6	—
Time 4 hours	5.3	—
Time 8 hours	7.3	—
Time 12 hours	7.1	—
Time 16 hours	6.4	—
Time 24 hours	5.0	—
4P-004 x mgTime [-4hours-0]	0	—
Time 2 hours	7.2	—
Time 4 hours	13.9	—
Time 8 hours	23.2	—
Time 12 hours	24.5	—
Time 16 hours	23.5	—
Time 24 hours	20.0	—
4P-004 y mgTime [-4hours-0]	0	—
Time 2 hours	58.1	—
Time 4 hours	90.4	—
Time 8 hours	123.7	—
Time 12 hours	122.2	—
Time 16 hours	113.6	—
Time 24 hours	95.2	—
4P-004 z mgTime [-4hours-0]	0	—
Time 2 hours	24.6	—
Time 4 hours	41.6	—
Time 8 hours	64.5	—
Time 12 hours	67.2	—
Time 16 hours	63.8	—
Time 24 hours	53.6	—

Secondary/protocol endpoint

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 (steady state)

concentration, descriptive

Other (unclassified)

2 endpoints

Other/protocol endpoint/low confidence

Exploratory Biomarkers Identification

Time frame:Day 1, Day 2, Day 8

descriptive

Other_pre_specified/registry result/low confidence

Exploratory Biomarkers Identification

Time frame:Day 1, Day 2, Day 8

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Liraglutide, a glucagon-like peptide 1 receptor agonist, exerts analgesic, anti-inflammatory and anti-degradative actions in osteoarthritis.
Scientific reports2022 Jan 28PMID35091584doi:10.1038/s41598-022-05323-7via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.