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NCT07116473
A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients With Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)
Phase 3 trial testing Acoramidis (AG10) in Amyloidosis in Transthyretin (TTR) in 250 participants. Not yet recruiting.
1 November 2037
Quick facts
| Lead sponsor | Eidos Therapeutics, a BridgeBio company |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 1 November 2025 |
| Primary completion | 1 November 2037 |
| Estimated completion | 1 December 2037 |
Drugs / interventions tested
- Acoramidis (AG10) — full drug profile →
Conditions studied
- Amyloidosis in Transthyretin (TTR) — all drugs for Amyloidosis in Transthyretin (TTR) →
- Amyloidosis, Familial — all drugs for Amyloidosis, Familial →
- Amyloid Cardiomyopathy — all drugs for Amyloid Cardiomyopathy →
- Amyloid Cardiomyopathy, Transthyretin-Related — all drugs for Amyloid Cardiomyopathy, Transthyretin-Related →
Sponsor
Eidos Therapeutics, a BridgeBio company — full company profile →
Who can join
18 and older, any sex, with Amyloidosis in Transthyretin (TTR) or Amyloidosis, Familial. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To evaluate the long-term safety and tolerability of acoramidis in participants with newly diagnosed ATTR-CM
Time frame: The duration of study participation for the participants will be up to 5 years.
Proportion of participants with: treatment-emergent AEs and SAEs, AEs leading to treatment discontinuation, abnormal physical examination findings of clinical relevance, abnormal vital signs of clinical relevance, abnormal ECG parameters of clinical relevance, changes in clinical safety laboratory parameters of potential concern
Sponsor's own description
The AG10-504 study is an open-label extension study of acoramidis in participants with newly diagnosed transthyretin amyloid cardiomyopathy (ATTR-CM) or both ATTR-CM and transthyretin amyloid polyneuropathy (ATTR-PN).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07116473
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Acoramidis (AG10)
Trials testing the same drug.
- NCT04988386 — Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants · Phase 3 · active not recruiting
Other recruiting trials for Amyloidosis in Transthyretin (TTR)
Currently open trials in the same condition.
- NCT07213297 — Comprehensive Program for Hereditary Transthyretin Amyloidosis · recruiting
- NCT07080268 — Validation of a Questionnaire for Quality of Life Assessment in Patients With Transthyretin Amyloidosis. · active not recruiting
Other Eidos Therapeutics, a BridgeBio company trials
Trials by the same sponsor.
- NCT04988386 — Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants · Phase 3 · active not recruiting
- NCT04769479 — A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects · Phase 1 · completed
- NCT04418024 — Efficacy and Safety of AG10 in Subjects with Transthyretin Amyloid Polyneurophathy · Phase 3 · withdrawn
- NCT03860935 — Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy · Phase 3 · completed
- NCT03458130 — Study of AG10 in Amyloid Cardiomyopathy · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07116473 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eidos Therapeutics, a BridgeBio company
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07116473.
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