A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

April 24, 2026 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of LTP001 in Healthy Adult Participants (Part A) and to Evaluate the Efficacy and Safety of LTP001 for the Treatment of Participants With Pulmonary Arterial Hypertension (Part B)

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The CLTP001A12202 study will explore the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers (Part A) and will evaluate the safety and efficacy (Part B) followed by safety extension in participants with pulmonary arterial hypertension.

Study Type

Interventional

Enrollment (Estimated)

232

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • CABA, Argentina, C1426ABP
        • Recruiting
        • Novartis Investigative Site
      • Río Cuarto, Argentina, X5800AEV
        • Recruiting
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentina, 4000
        • Recruiting
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EOZ
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1199
        • Recruiting
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Novartis Investigative Site
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Novartis Investigative Site
      • New Lambton Heights, New South Wales, Australia, 2305
        • Recruiting
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Novartis Investigative Site
  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Recruiting
        • Novartis Investigative Site
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Prague, Czechia, 128 08
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 14021
        • Recruiting
        • Novartis Investigative Site
  • France
      • Brest, France, 29200
        • Recruiting
        • Novartis Investigative Site
      • Clamart, France, 92141
        • Recruiting
        • Novartis Investigative Site
      • Grenoble, France, 38043
        • Recruiting
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Recruiting
        • Novartis Investigative Site
      • Nice, France, 06001
        • Recruiting
        • Novartis Investigative Site
      • Pessac, France, 33604
        • Recruiting
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Recruiting
        • Novartis Investigative Site
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • Novartis Investigative Site
      • Strasbourg, France, 67091
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31059
        • Recruiting
        • Novartis Investigative Site
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • Novartis Investigative Site
    • France
      • Angers, France, France, 49933
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 14050
        • Recruiting
        • Novartis Investigative Site
      • Giessen, Germany, 35392
        • Recruiting
        • Novartis Investigative Site
      • Greifswald, Germany, 17475
        • Recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Recruiting
        • Novartis Investigative Site
      • Homburg, Germany, 66421
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 106 76
        • Recruiting
        • Novartis Investigative Site
      • Chaïdári, Greece, 124 62
        • Recruiting
        • Novartis Investigative Site
      • Thessaloniki, Greece, 54636
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • FG
      • Foggia, FG, Italy, 71122
        • Recruiting
        • Novartis Investigative Site
    • MB
      • Monza, MB, Italy, 20900
        • Recruiting
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Recruiting
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Recruiting
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italy, 07100
        • Recruiting
        • Novartis Investigative Site
    • TO
      • Ivrea, TO, Italy, 10015
        • Recruiting
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italy, 34149
        • Recruiting
        • Novartis Investigative Site
  • Latvia
      • Riga, Latvia, LV 1002
        • Recruiting
        • Novartis Investigative Site
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Novartis Investigative Site
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78200
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Poznan, Poland, 61 545
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • Novartis Investigative Site
      • Lisbon, Portugal, 1769 001
        • Recruiting
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 050159
        • Recruiting
        • Novartis Investigative Site
    • Timiș County
      • Timișoara, Timiș County, Romania, 300310
        • Recruiting
        • Novartis Investigative Site
  • Serbia
      • Kamenitz, Serbia, 21204
        • Recruiting
        • Novartis Investigative Site
      • Niš, Serbia, 18108
        • Recruiting
        • Novartis Investigative Site
    • Serbia
      • Belgrade, Serbia, Serbia, 11000
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Seville, Spain, 41013
        • Recruiting
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Novartis Investigative Site
    • Andalusia
      • Marbella, Andalusia, Spain, 29600
        • Recruiting
        • Novartis Investigative Site
    • Castille-La Mancha
      • Toledo, Castille-La Mancha, Spain, 45071
        • Recruiting
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Recruiting
        • Novartis Investigative Site
    • Las Palmas
      • Las Palmas de Gran C, Las Palmas, Spain, 35016
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0AY
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SW3 6PH
        • Recruiting
        • Novartis Investigative Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Arizona Pulmonary Specialists Ltd
        • Contact:
          • Phone Number: +1 602 271 0832
        • Principal Investigator:
          • Akshay Muralidhar
    • California
      • Orange, California, United States, 92868-3298
        • Recruiting
        • UC Irvine Medical Center
        • Contact:
          • Phone Number: +1 714 456 6037
        • Principal Investigator:
          • Bassam Yaghmour
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Medical Center
        • Contact:
          • Phone Number: +1 650 725 5495
        • Principal Investigator:
          • Roham Zamanian
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Univ Colorado Hospital
        • Contact:
          • Phone Number: +1 720 848 6567
        • Principal Investigator:
          • David B Badesch
    • Florida
      • Orlando, Florida, United States, 32803-5734
        • Recruiting
        • Central Florida Pulmonary Group
        • Contact:
          • Phone Number: +1 407 841 1100
        • Principal Investigator:
          • Syed Mobin
      • Tampa, Florida, United States, 33606-3475
        • Recruiting
        • University of South Florida
        • Contact:
          • Phone Number: +1 813 844 7137
        • Principal Investigator:
          • Ricardo Restrepo-Jaramillo
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine
        • Contact:
          • Phone Number: +1 404 778 3261
        • Principal Investigator:
          • Micah Fisher
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • U of Kansas Medical Center
        • Contact:
          • Phone Number: +1 913 588 9722
        • Principal Investigator:
          • Leslie Spikes
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Infectious Diseases Specialists
        • Contact:
          • Phone Number: +1 502 587 8000
        • Principal Investigator:
          • John Wesley McConnell
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Nicholas Hill
        • Contact:
          • Phone Number: +1 617 636 4288
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital and Medical Center
        • Principal Investigator:
          • Ioana Preston
        • Contact:
          • Phone Number: +1 781 744 3874
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157-5179
        • Recruiting
        • Sky Integrative Medical Center SKYCRNG PPDS
        • Principal Investigator:
          • Bob Hutchins
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Summit Health Eastside Clinic
        • Principal Investigator:
          • Jeremy Feldman
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212-4756
        • Recruiting
        • Allegheny General Hospital
        • Principal Investigator:
          • Hayah Kassis-George
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Recruiting
        • StatCare Pulmonary Consultants
        • Principal Investigator:
          • John Swisher
    • Texas
      • Austin, Texas, United States, 78744
        • Recruiting
        • PPD Development LP
        • Contact:
          • Phone Number: +1 512 447 2985
        • Principal Investigator:
          • Jia Chang
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • Kelly Chin
        • Contact:
          • Phone Number: +1 214 645 6488
    • Utah
      • Salt Lake City, Utah, United States, 84132-0001
        • Recruiting
        • The University of Utah
        • Contact:
          • Phone Number: +1 801 213 4086
        • Principal Investigator:
          • Katharine Clapham
    • Virginia
      • Richmond, Virginia, United States, 23230-1709
        • Recruiting
        • Pul Ass Richmond Inc P A R
        • Principal Investigator:
          • Shilpa Johri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Part A Inclusion Criteria:

  • Healthy males and non-child-bearing potential females

Part A Exclusion Criteria:

  • Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study Other protocol-defined inclusion/exclusion criteria may apply.
  • For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation Japanese as defined in inclusion criteria 7 of the protocol.

Part B Inclusion Criteria:

-Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m.

Part B Exclusion Criteria:

Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study Women of child-bearing potential unless they are using highly effective methods of contraception Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment.

History of hypersensitivity to any of the study treatments or excipients

Other protocol-defined inclusion / exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
matching placebo
Drug: Placebo
Placebo
Experimental: LTP001 Dose 1
Drug: LTP
LTP001
Experimental: LTP001 Dose 2
Drug: LTP
LTP001
Experimental: LTP001 Dose 3
Drug: LTP
LTP001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time Frame: Baseline to Day 35
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit.
Baseline to Day 35
Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
Time Frame: Baseline to Week 24
PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization.
Baseline to Week 24
Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time Frame: From Day 1 until Week 106
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.
From Day 1 until Week 106

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A- Maximum observed plasma concentrations (Cmax)
Time Frame: Baseline to Day 35
Cmax is defined as the maximum (peak) observed concentration following a dose.
Baseline to Day 35
Part A- Time to reach maximum plasma concentration (Tmax)
Time Frame: Baseline to Day 35
Tmax is defined as the time to reach maximum (peak) concentration following a dose.
Baseline to Day 35
Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
Time Frame: Baseline to Day 35
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast).
Baseline to Day 35
Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
Time Frame: Baseline to Day 35
The AUC is the area under the plasma concentration from time zero to infinity (mass x time x volume-1).
Baseline to Day 35
Part A- Terminal elimination half-life (T1/2)
Time Frame: Baseline to Day 35
T1/2 is the elimination half-life associated with the terminal slope.
Baseline to Day 35
Part B-Treatment Period 1: Change in the Six-minute Walk Test (6MWT)
Time Frame: Baseline to Week 24
The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor.
Baseline to Week 24
Part B-Treatment Period 1: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame: Baseline to Week 24
N-terminal pro brain natriuretic peptide (NTproBNP) are peptide (small proteins) that are either hormones or part of the peptide that contained the hormone at one time. They are continually produced in small quantities in the heart and released in larger quantities when the heart senses that it needs to work harder, as in heart failure.
Baseline to Week 24
Part B-Treatment Period 1: Change in World Health Organization (WHO) functional class (FC)
Time Frame: Baseline to Week 24

The Investigator or study staff will assign a WHO functional class to a participant based on reports of symptoms and activity limitation.

  • Class I: symptom-free when physically active or resting.
  • Class II: no symptoms at rest, but normal activities such as climbing the stairs, grocery shopping, or making the bed cause some discomfort and shortness of breath.
  • Class III: resting may be symptom-free, but normal chores around the house are greatly limited due to shortness of breath and feeling tired.
  • Class IV: symptoms at rest and severe symptoms with an activity
Baseline to Week 24
Part B-Treatment Period 2: Change in the Six-minute Walk Test (6MWT)
Time Frame: Baseline to Month 18
The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor.
Baseline to Month 18
Part B-Treatment Period 2: Change in World Health Organization (WHO) functional class (FC)
Time Frame: Baseline to Month 18

The Investigator or study staff will assign a WHO functional class to a participant based on reports of symptoms and activity limitation.

  • Class I: symptom-free when physically active or resting.
  • Class II: no symptoms at rest, but normal activities such as climbing the stairs, grocery shopping, or making the bed cause some discomfort and shortness of breath.
  • Class III: resting may be symptom-free, but normal chores around the house are greatly limited due to shortness of breath and feeling tired.
  • Class IV: symptoms at rest and severe symptoms with an activity
Baseline to Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

November 29, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTP001A12202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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