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Transthyretin Stabilizer

acoramidis for Heart Disease (ATTRibute-CM Trial)

Phase 3

Waitlist Available

Research Sponsored by Eidos Therapeutics, a BridgeBio company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months and 30 months

Awards & highlights

Pivotal Trial

Summary

This trial tests acoramidis, a pill taken regularly, in patients with ATTR-CM, a heart condition caused by protein buildup. The drug aims to prevent these proteins from clumping together and damaging the heart.

Eligible Conditions

Heart Disease
Amyloid Cardiomyopathy
Single Ventricle Heart Disease
Amyloidosis
Cardiomyopathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months and 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A Hierarchical Combination of All-Cause Mortality, Cumulative Frequency of CV-related Hospitalization, Change From Baseline in NT-proBNP and Change From Baseline in 6MWT at the Last Available Visit Where Both Subjects Had Non-missing Assessments.

Secondary study objectives

All-cause Mortality by Month 30, Including Death Due to Any Cause, Heart Transplant or Cardiac Mechanical Assist Device (CMAD)

Change From Baseline to Month 30 in Serum TTR (Prealbumin) Level

Change From Baseline to Month 30 in the Distance Walked During the 6 Minute Walk Test (6MWT)

+1 more

Other study objectives

Assess acoramidis activity across TTR mutations

Characterize PK of acoramidis

Effects of acoramidis on circulating biomarker of microvascular ischemia

+2 more

Side effects data

From 2023 Phase 3 trial • 632 Patients • NCT03860935

19%

COVID-19

16%

Cardiac failure

14%

Fall

13%

Atrial fibrillation

12%

Dyspnoea

12%

Constipation

11%

Diarrhoea

11%

Dizziness

11%

Gout

11%

Arthralgia

11%

Urinary tract infection

10%

Fatigue

Back pain

Renal impairment

Muscle spasms

Cough

Oedema peripheral

Acute kidney injury

Anaemia

Pain in extremity

Hypotension

Nausea

Blood creatinine increased

Pruritus

Hypervolaemia

Abdominal pain upper

Asthenia

Epistaxis

Cardiac failure acute

Upper respiratory tract infection

Nasopharyngitis

Hypokalaemia

Decreased appetite

Rash

Insomnia

Haematuria

Syncope

Weight decreased

Basal cell carcinoma

Skin laceration

Pneumonia

Ventricular tachycardia

Bradycardia

Cellulitis

Atrioventricular block complete

Peripheral swelling

Cerebrovascular accident

Sinus node dysfunction

Presyncope

Cerebral infarction

Death

Cardiac failure chronic

Acute myocardial infarction

Cardiac arrest

Cardiac failure congestive

Cardiorenal syndrome

Atrial flutter

Acute left ventricular failure

Lower respiratory tract infection

Sepsis

Septic shock

Rib fracture

Femoral neck fracture

Ankle fracture

Inguinal hernia

Gastrointestinal haemorrhage

Dyspnoea exertional

Osteoarthritis

Orthostatic hypotension

Aortic stenosis

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Acoramidis HCl 800 mg

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: acoramidis HCl 800 mgExperimental Treatment1 Intervention

Subjects will receive acoramidis HCl 800 mg twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive placebo to match twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

acoramidis

2021

Completed Phase 3

~650

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