Knee OsteoarthritisPhase 1LASARENCT05419856
Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL 2-4 Osteoarthritic Knee
A Phase 1 study testing 4P-004 in people with Knee Osteoarthritis, run by 4Moving Biotech at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- 4P-004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesBelgium
- Study dates
- 9 Aug 2022to 31 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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]).
Who cannot join
- 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,
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- 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.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
UCL-St Luc
Brussels, 1200
AZMaria Middelares
Ghent, 9000
UZ Leuven
Leuven, 3000
About this study
Official title: 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
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
- Being tested
- 4P-004, Placebo
- Keywords
- OA, Knee OA, Liraglutide
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4P-004Drug
Also called Liraglutide
single intraarticular administration in the knee joint
PlaceboDrug
Also called NaCl
single intraarticular administration in the knee joint
| Study group | Role | What they receive |
|---|---|---|
| 4P-004 w mg | Experimental | 4P-004 is administered once intraarticularly in the target knee joint Dose = w mg Receives: Drug: 4P-004 |
| 4P-004 x mg | Experimental | 4P-004 is administered once intraarticularly in the target knee joint Dose = x mg Receives: Drug: 4P-004 |
| 4P-004 y mg | Experimental | 4P-004 is administered once intraarticularly in the target knee joint Dose = y mg Receives: Drug: 4P-004 |
| 4P-004 z mg | Experimental | 4P-004 is administered once intraarticularly in the target knee joint Dose = z mg Receives: Drug: 4P-004 |
| Placebo | Placebo comparator | Placebo is administered once intraarticularly in the target knee joint Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Day 1 to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start9 Aug 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Moving Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419856
- Sponsor's protocol ID
- 4MB-LAS-P
- Acronym
- LASARE
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2022
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35091584
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05419856
- Acronym / sponsor ID
- LASARE / 4MB-LAS-P
- Conditions
- Knee Osteoarthritis
- Keywords
- OA, Knee OA, Liraglutide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- 4Moving BiotechIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).
| Arm | Type | Receives |
|---|---|---|
| 4P-004 w mg | Experimental | Drug: 4P-0044P-004 is administered once intraarticularly in the target knee joint Dose = w mg |
| 4P-004 x mg | Experimental | Drug: 4P-0044P-004 is administered once intraarticularly in the target knee joint Dose = x mg |
| 4P-004 y mg | Experimental | Drug: 4P-0044P-004 is administered once intraarticularly in the target knee joint Dose = y mg |
| 4P-004 z mg | Experimental | Drug: 4P-0044P-004 is administered once intraarticularly in the target knee joint Dose = z mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered once intraarticularly in the target knee joint |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (18 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4P-004Also: Liraglutidesingle intraarticular administration in the knee joint | Drug | 4P-004 w mg, 4P-004 x mg, 4P-004 y mg, 4P-004 z mg |
| PlaceboAlso: NaClsingle intraarticular administration in the knee joint | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35091584Meurot 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.
- 4Moving Biotech (sponsor) web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4P-004 in people with Knee Osteoarthritis, run by 4Moving Biotech at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA. (time frame: Day 1-Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.