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

NCT05419856 | Completed Phase 1 Results DMC

• 1 other identifier: 4MB-LAS-P
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Knee Osteoarthritis

Keywords

OA; Knee OA; Liraglutide

Outcome Measures

Primary Outcomes (1)

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

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

  Day 1-Day 28

Secondary Outcomes (1)

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

  Day 1 to Day 2

Other Outcomes (1)

• Exploratory Biomarkers Identification

  Day 1, Day 2, Day 8

Study Arms (5)

4P-004 w mg

EXPERIMENTAL

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

Drug: 4P-004

4P-004 x mg

EXPERIMENTAL

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

Drug: 4P-004

4P-004 y mg

EXPERIMENTAL

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

Drug: 4P-004

4P-004 z mg

EXPERIMENTAL

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

Drug: 4P-004

Placebo

PLACEBO COMPARATOR

Placebo is administered once intraarticularly in the target knee joint

Drug: Placebo

Interventions

4P-004 DRUG

single intraarticular administration in the knee joint

Also known as: Liraglutide

4P-004 w mg; 4P-004 x mg; 4P-004 y mg; 4P-004 z mg

Placebo DRUG

single intraarticular administration in the knee joint

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• 4Moving Biotech: lead

Study Sites (3)

UCL-St Luc

Brussels, 1200, Belgium

Location

AZMaria Middelares

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Meurot C, Martin C, Sudre L, Breton J, Bougault C, Rattenbach R, Bismuth K, Jacques C, Berenbaum F. Liraglutide, a glucagon-like peptide 1 receptor agonist, exerts analgesic, anti-inflammatory and anti-degradative actions in osteoarthritis. Sci Rep. 2022 Jan 28;12(1):1567. doi: 10.1038/s41598-022-05323-7.

  PMID: 35091584 BACKGROUND

Related Links

• 4Moving Biotech (sponsor) web site

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Odile Fleurot
• Organization: 4Moving Biotech

odile.fleurot@4p-pharma.com

03 20 11 80 30

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 15, 2022
• Study Start: August 9, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: June 26, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)