Achilles TendinopathyPhase 2NCT05592990
A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy
A Phase 2 study testing NGI226 in people with Achilles Tendinopathy, run by Novartis Pharmaceuticals at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- NGI226
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 14 Jun 2023to 3 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
Advanced Research LLC
Deerfield Beach, Florida, 33064
Houston Methodist Hospital
Houston, Texas, 77030
Tucson Orthopedic Institute PC
Tucson, Arizona, 85712
Germany3 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Hamburg, 20149
Novartis Investigative Site
Hamburg, 22415
About this study
Official title: 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
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.
- Conditions
- Achilles Tendinopathy
- Being tested
- NGI226, Placebo
- Keywords
- Achilles tendon; mid-portion Achilles tendinopathy; peritendon injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGI226Drug
NGI226 MP
PlaceboDrug
Placebo MP
| Study group | Role | What they receive |
|---|---|---|
| NGI226 | Experimental | single peritendon injection Receives: Drug: NGI226 |
| Placebo | Placebo comparator | single peritendon injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with AEs and SAEs
AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability
Measured: Up to Day 169 (End of Study)
Secondary outcomes (1)
Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)
To assess the effects of a single peritendon injection of NGI226 MP versus placebo on restoration of biomechanical integrity of Achilles tendon
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start14 Jun 2023
- Primary completion3 Feb 2026
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592990
- Sponsor's protocol ID
- CNGI226A12201
- Other IDs
- 2022-500863-10-00
- Status last verified
- Sep 2026
- First submitted
- 20 Oct 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05592990
- Acronym / sponsor ID
- CNGI226A12201
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles tendon; mid-portion Achilles tendinopathy; peritendon injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGI226 | Experimental | Drug: NGI226single peritendon injection |
| Placebo | Placebo comparator | Drug: Placebosingle peritendon injection |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| NGI226NGI226 MP | Drug | NGI226 |
| PlaceboPlacebo MP | Drug | Placebo |
Primary outcome
Number of participants with AEs and SAEs
Time frame: Up to Day 169 (End of Study)
AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability
1 secondary outcome
Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)
Time frame: Baseline, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NGI226 in people with Achilles Tendinopathy, run by Novartis Pharmaceuticals at 7 sites in 3 countries.
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 3 inclusion and 6 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with AEs and SAEs (time frame: Up to Day 169 (End of Study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.