A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy

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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05592990

Enrollment

Registered

2022-10-25

Start date

2023-06-14

Completion date

2026-02-03

Last updated

2026-09-09

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

Conditions

Achilles Tendinopathy

Keywords

Achilles tendon; mid-portion Achilles tendinopathy; peritendon injection

Brief summary

The purpose of this study is to measure local and systemic safety and tolerability as well as improvement of Achilles tendon mechanical properties after a single peritendon injection of NGI226 MP in comparison to placebo MP in patients with mid-portion Achilles tendinopathy.

Interventions

DRUGNGI226

NGI226 MP

DRUGPlacebo

Placebo MP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Written informed consent must be obtained prior to all study specific screening procedures, as close to the start of the screening period as possible. * Presence of clinically (local Achilles tendon pain on tendon-loading activities, pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and ultrasound (local tendon thickening with hypoechogenicities and irregular fibre orientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptoms present ≥8 weeks but \<12 months at screening. * The Achilles tendinopathy must have been refractory to at least 6 weeks of conservative treatment (physiotherapy, NSAIDS, RICE), but participants do not need to be in physiotherapy at the time of study entry.

Exclusion criteria

* Medical condition that would affect safety of peritendon injection (e.g., peripheral vascular disease, use of anticoagulant medication) * History of recurrent, acute, symptomatic infections, including outbreaks of oral or genital herpes (\> 2 symptomatic infections or \>2 courses of anti-infective treatments required in the last 6 months; active systemic infection during last 2 weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simple cold excluded * History or evidence of clinically significant cardiac or cardiovascular disease * History of deep vein thrombosis, pulmonary embolism or evidence of primary or secondary hypercoagulable states * History of surgical intervention for the treatment of tendinopathy, history of ankle surgery, ankle arthritis, traumatic, inflammation or deformity of ankle * History of full-thickness tear or complete rupture of the Achilles tendon

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with AEs and SAEs	Up to Day 169 (End of Study)	AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability

Secondary

Measure	Time frame	Description
Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)	Baseline, Week 12	To assess the effects of a single peritendon injection of NGI226 MP versus placebo on restoration of biomechanical integrity of Achilles tendon

Countries

France, Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026