A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

PHASE2RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 8, 2024

Primary Completion Date

October 9, 2026

Study Completion Date

November 20, 2026

Conditions
Pulmonary HypertensionHeart Failure With Preserved Ejection Fraction
Interventions
DRUG

TX000045- Dose A

The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.

DRUG

TX000045- Dose B

The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.

DRUG

Placebo

The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.

Trial Locations (63)

1070

NOT_YET_RECRUITING

Brussel, Brussels

1700

RECRUITING

Sofia, Sofia

1750

NOT_YET_RECRUITING

Sofia, Sofia

2010

NOT_YET_RECRUITING

Sydney, Sydney

2109

RECRUITING

Macquarie, Macquarie

2500

RECRUITING

Wollongong, Wollongong

3144

RECRUITING

Malvern, Malvern

3600

NOT_YET_RECRUITING

Genk, Genk

4001

RECRUITING

Plovdiv, Plovdiv

4032

RECRUITING

Chermside, Chermside

4066

RECRUITING

Auchenflower, Auchenflower

5800

RECRUITING

Pleven, Pleven

7000

RECRUITING

Hobart, Hobart

8011

RECRUITING

Christchurch, Christchurch

9016

NOT_YET_RECRUITING

Dunedin, Dunedin

10029

NOT_YET_RECRUITING

New York, New York

10075

NOT_YET_RECRUITING

New York, New York

15213

NOT_YET_RECRUITING

Pittsburgh, Pittsburgh

15706

RECRUITING

Santiago de Compostela ( Coruña ), Santiago de Compostela

17403

NOT_YET_RECRUITING

York, York

20246

NOT_YET_RECRUITING

Hamburg, Hamburg

21201

NOT_YET_RECRUITING

Baltimore, Baltimore

27710

NOT_YET_RECRUITING

Durham, Durham

28034

RECRUITING

Madrid, Madrid

28041

NOT_YET_RECRUITING

Madrid, Madrid

29732

RECRUITING

Rock Hill, Rock Hill

30253

NOT_YET_RECRUITING

McDonough, McDonough

30912

NOT_YET_RECRUITING

Augusta, Augusta

32216

NOT_YET_RECRUITING

Jacksonville, Jacksonville

33613

NOT_YET_RECRUITING

Tampa, Tampa

35205

NOT_YET_RECRUITING

Birmingham, Birmingham

39216

RECRUITING

Jackson, Jackson

43606

RECRUITING

Toledo, Toledo

46010

RECRUITING

Valencia, Valencia

46015

NOT_YET_RECRUITING

Valencia, Valencia

55131

NOT_YET_RECRUITING

Mainz, Mainz

60453

NOT_YET_RECRUITING

Chicago, Chicago

63110

RECRUITING

St Louis, St Louis

68105

NOT_YET_RECRUITING

Omaha, Omaha

70433

RECRUITING

Covington, Covington

76712

RECRUITING

Waco, Waco

77642

RECRUITING

Port Arthur, Port Arthur

77702

RECRUITING

Beaumont, Beaumont

80045

RECRUITING

Aurora, Aurora

84112

NOT_YET_RECRUITING

Salt Lake City, Salt Lake City

85258

RECRUITING

Scottsdale, Scottsdale

94143

NOT_YET_RECRUITING

San Francisco, San Francisco

200642

NOT_YET_RECRUITING

Craiova, Craiova

540136

RECRUITING

Targu Mures, Târgu Mureş

02180

RECRUITING

Boston, Boston

0006

RECRUITING

Yerevan, Yerevan

0025

RECRUITING

Yerevan, Yerevan

0087

RECRUITING

Yerevan, Yerevan

0186

RECRUITING

Tbilisi, Tbilisi

0167

RECRUITING

Tbilisi, Tbilisi

LV10002

NOT_YET_RECRUITING

Riga, Riga

Unknown

RECRUITING

Chisinau, Chisinau

15-276

RECRUITING

Białystok, Bialystok

31-202

NOT_YET_RECRUITING

Krakow, Krakow

91-347

NOT_YET_RECRUITING

Łodź, Lodz

20-090

NOT_YET_RECRUITING

Lublin, Lublin

04-628

NOT_YET_RECRUITING

Warsaw, Warsaw

08035

RECRUITING

Barcelona, Barcelona

Sponsors
All Listed Sponsors
lead

Tectonic Therapeutic

INDUSTRY

NCT06616974 - A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) | Biotech Hunter | Biotech Hunter