A clinical study of sotatercept in people with pulmonary arterial hypertension (MK-7962-024)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

9 Dec 2024 → 15 Jan 2026

Decision date (initial)

2024-11-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-512278-92-00

WHO UTN

U1111-1304-7985

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Dose response, Diagnosis, Safety, Pharmacogenomic, Pharmacokinetic, Pharmacodynamic, Pharmacogenetic

1. To evaluate the steady-state systemic exposure of sotatercept using weight-banded dosing relative to the exposure using weight-based dosing following multiple (maintenance doses) dose administration at steady state.
2. To evaluate the safety and tolerability of sotatercept over 24 weeks of treatment

Secondary objectives 1

1. To evaluate the systemic exposure of sotatercept using weight-banded dosing relative to the exposure using weight-based dosing following initial dose administration.

Conditions and MedDRA coding

Pulmonary Arterial Hypertension (PAH)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
2. Has systemic PAH classified as WHO Functional Class II or III

Exclusion criteria 16

1. Has weight of <35kg
2. Has diagnosis of Pulmonary Hypertension WHO Groups 2, 3, 4, or 5
3. Has a diagnosis of the following PAH Group 1 subtypes: Human Immunodeficiency Virus (HIV)-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 also includes: schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
4. Has uncontrolled systemic hypertension
5. Has a history of pneumonectomy
6. Has a history of known pericardial constriction
7. Has a history of restrictive cardiomyopathy
8. Has a history of atrial septostomy (within 180 days prior to study start)
9. Has personal or family history of long QT syndrome
10. Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
11. Has a cerebrovascular accident (within 3 months prior to study start)
12. Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
13. Has untreated more than mild obstructive sleep apnea
14. Has known malignancy that is progressing or has required active treatment within the past 5 years
15. Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
16. Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Steady-state average serum concentrations of sotatercept (Cavg)
2. Number of participants who experience one or more adverse events (AEs)
3. Number of participants who discontinue study intervention due to an AE

Secondary endpoints 1

1. Initial dose average serum concentrations of sotatercept (Cavg)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Michela Brambatti

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Michela Brambatti

Third parties 7

Locations

8 EU/EEA countries · 37 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 66 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications