Transthyretin Amyloid Cardiomyopathy (ATTR-CM)MOSAIC-TTRNCT07791160
Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy
An observational study of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), run by Bayer at 1 site in France.
Trial summary
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive heart disease caused by the buildup of an abnormal protein, called transthyretin (TTR), in the heart. This buildup can make it harder for the heart to pump blood and may lead to worsening symptoms over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
- What is being tested?
- Acoramidis
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2026to 31 Dec 2028
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from centers that are part of the French Amyloidosis Network or centers that are knowledgeable in the diagnosis and management of transthyretin amyloid cardiomyopathy (ATTR-CM). There are two complementary enrollment pathways: (i) direct recruitment within this study, and (ii) integration of data from the Healthcare Amyloidosis European Registry (HEAR), a multicenter registry maintained by reference centers (see NCT05101304), to enrich the study database.
Who may be able to join
- Greater than or equal to 18 years of age
- Established diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype
- Initiating treatment with acoramidis with the decision to treat having been made by the treating physician prior to study enrolment in accordance with the current French Summary of Product Characteristics (SmPC)
Who cannot join
- Any contraindications as listed in the local approved product information
- Prior treatment with disease-modifying treatment (e.g., tafamidis, TTR silencers and/or depleters)
- Participation in an investigational trial evaluating new Investigational Medicinal Products or new Investigational Medical Device outside of routine clinical practice
- Under legal protection (guardianship, curatorship, or other legal protection measures) or deprived of liberty by administrative or judicial decision at the time of inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Longitudinal, Multi-center, Observational Study of Acoramidis In Patients With Wild-type or Variant Transthyretin Amyloid Cardiomyopathy (ATTR-CM): MOSAIC-TTR Study
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive heart disease caused by the buildup of an abnormal protein, called transthyretin (TTR), in the heart. This buildup can make it harder for the heart to pump blood and may lead to worsening symptoms over time. Acoramidis is a medicine approved for the treatment of adults with wild-type or hereditary (variant) ATTR-CM. While its benefits have been demonstrated in clinical trials, more information is needed about how it is used and how patients do in everyday medical practice.
The MOSAIC-TTR study is an observational study in France. Participants will receive acoramidis as part of their usual medical care. No experimental treatments or additional medical procedures will be required. The study will collect information directly from participating hospitals and from the Healthcare European Amyloidosis Registry (HEAR; NCT05101304). The main goal of the study is to understand how patients' quality of life, daily functioning, and overall well-being change during the first 12 months of treatment with acoramidis, using questionnaires completed by the patients themselves. The study will also collect information about the characteristics of patients receiving acoramidis, how the medicine is used in routine clinical practice, and its safety and tolerability. The information collected will help improve the understanding of ATTR-CM and may help improve the care of people living with this condition.
- Being tested
- Acoramidis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcoramidisDrug
Also called BAY3684938, BEYONTTRA
356 mg film-coated tablets. The recommended dose is 712 mg (two tables, 356 mg) orally twice daily, corresponding to a total daily dose of 1424 mg.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Patients will receive acoramidis 712 mg orally BID (twice daily) Receives: Drug: Acoramidis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome Measure: Amylo-AFFECT-QOL score
Change from baseline in Amylo-AFFECT-QOL total score
Measured: At 3, 6, 9, and 12 months after initiation of acoramidis
Patient Reported Outcome Measure: KCCQ-23 score
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) total score
Measured: At 3, 6, 9, and 12 months after initiation of acoramidis
Patient Reported Outcome Measure: EQ-5D-3L index score
3L index score of EQ-5D Health-Related Quality of Life Questionnaire
Measured: At 3, 6, 9, and 12 months after initiation of acoramidis
Patient Reported Outcome Measure: EQ VAS score
Visual Analog scale score of EQ-5D Health-Related Quality of Life Questionnaire
Measured: At 3, 6, 9, and 12 months after initiation of acoramidis
Secondary outcomes (14)
Demographic characteristics: Age
Age of patients initiating treatment with acoramidis
Measured: Before treatment with acoramidis
Demographic characteristics: Sex
Sex of patients initiating treatment with acoramidis
Measured: Before treatment with acoramidis
Demographic characteristics: Body Mass Index
Body Mass Index of patients initiating treatment with acoramidis
Measured: Before treatment with acoramidis
Clinical characteristics: Time between diagnosis and treatment initiation
Time between ATTR-CM diagnosis and treatment initiation
Measured: Before treatment with acoramidis
Clinical characteristics: ATTR-CM diagnosis
ATTR-CM diagnosis (genetic status including mutation type [if applicable], phenotype)
Measured: Before treatment with acoramidis
Clinical characteristics: ATTR-CM manifestations
ATTR-CM manifestations prior to treatment initiation
Measured: Before treatment with acoramidis
Clinical characteristics: Comorbidities
ATTR-CM-relevant comorbidities that were either ongoing at treatment initiation, or were previously managed or resolved in the 12 months prior to initiating acoramidis, as well as those that began after initiating acoramidis
Measured: Up to 12 months before initiation of acoramidis, and during treatment with acoramidis
Clinical characteristics: Prior medication and procedures
Prior medication taken and procedures performed up to 12 months before initiation of acoramidis
Measured: Up to 12 months before initiation of acoramidis
Treatment patterns: Treatment duration
Duration of treatment with acoramidis
Measured: During treatment with acoramidis
Treatment patterns: Treatment interruptions
Proportion of patients with temporary treatment interruptions and reason for interruption
Measured: During treatment with acoramidis
Treatment patterns: Treatment discontinuation
Proportion of patients with permanent treatment discontinuation and reason for discontinuation
Measured: During treatment with acoramidis
Treatment patterns: Time to treatment discontinuation
Time to acoramidis treatment discontinuation
Measured: During treatment with acoramidis
Treatment patterns: Concomitant medications and procedures
Concomitant medications taken and procedures performed during treatment with acoramidis
Measured: During treatment with acoramidis
Safety and tolerability: Adverse events
Adverse events (AEs) occurring during treatment with acoramidis and AEs occurring up to 6 days after the last intake of acoramidis if premature permanent treatment discontinuation
Measured: During treatment with acoramidis and up to 6 days after the last intake of acoramidis in case of premature permanent treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start7 Sep 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Studies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Saving Lives Matters, Heart's Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791160
- Sponsor's protocol ID
- 23181
- Acronym
- MOSAIC-TTR
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Publications
Gillmore JD, Judge DP, Cappelli F, Fontana M, Garcia-Pavia P, Gibbs S, Grogan M, Hanna M, Hoffman J, Masri A, Maurer MS, Nativi-Nicolau J, Obici L, Poulsen SH, Rockhold F, Shah KB, Soman P, Garg J, Chiswell K, Xu H, Cao X, Lystig T, Sinha U, Fox JC; ATTRibute-CM Investigators. Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2024 Jan 11;390(2):132-142. doi: 10.1056/NEJMoa2305434.
PubMed 38197816Reant P, Kharoubi M, Donal E, Bauer F, Bezard M, Bisson A, Bodez D, Bouchot O, Cariou E, Charron P, Costa J, Courand PY, Dagrenat C, Delelis F, Duval AJ, Eicher JC, Fraix A, Gellen B, Gueffet JP, Guijarro D, Habib G, Hagege A, Huttin O, Jaccard A, Jeanneteau J, Legallois D, Logeart D, Legrand L, Inamo J, Marguerit L, Mirailles R, Pezel T, Piriou N, Roubille F, Mouhat B, Tresorier R, Von Hunolstein JJ, Taieb C, Salvat M, Zaroui A, Lairez O, Damy T. The Healthcare Amyloidosis European Registry (HEAR): design of a national registry with a European extension strategy, and foundation of the F-CRIN GRACE network. Orphanet J Rare Dis. 2025 Oct 27;20(1):534. doi: 10.1186/s13023-025-04062-y.
PubMed 41139783