A two part, randomized, participant and investigator-blinded, 2-arm, parallel-design, placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of NGI226 microparticles on tendon regeneration in patients with Achilles tendinopathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500863-10-00

Acronym

CNGI226A12201

Enrollment

Registered

2022-12-06

Start date

2023-10-18

Completion date

Unknown

Last updated

2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendinopathy

Brief summary

Part A and Part B: • Local and systemic treatment Emergent Adverse Events (TEAEs) and serious TEAEs • Local tolerability (changes in pain, swelling, redness, warmth, range of motion and itching, infection, tendon physical examination) • Laboratory tests (clinical chemistry, hematology, coagulation, Liver Function Test (LFT), urinalysis) • Electrocardiogram parameters (ECGs) • Vital signs (blood pressure, pulse rate, body, temperature)

Detailed description

Part A and Part B: Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)

Interventions

DRUGNGI226

DRUGPlacebo to NGI226 100 mg Powder for suspension for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A and Part B: • Local and systemic treatment Emergent Adverse Events (TEAEs) and serious TEAEs • Local tolerability (changes in pain, swelling, redness, warmth, range of motion and itching, infection, tendon physical examination) • Laboratory tests (clinical chemistry, hematology, coagulation, Liver Function Test (LFT), urinalysis) • Electrocardiogram parameters (ECGs) • Vital signs (blood pressure, pulse rate, body, temperature)	—

Measure

Time frame

—

Secondary

Measure	Time frame
Part A and Part B: Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)	—

Countries

France, Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026