Recruiting
Phase 1
Phase 2

LTP001

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06649110

Conditions

Healthy Volunteers, Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LTP

Placebo

Study Details

Brief summary:

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

Conditions

Healthy Volunteers, Pulmonary Arterial Hypertension

Study ID

NCT06649110

Start date

Oct 24, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Nov 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

232 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LTP001 Dose 1

experimental: LTP001 Dose 2

experimental: LTP001 Dose 3

placebo comparator: Placebo

matching placebo

Interventions

LTP

LTP001

Placebo

Placebo

Primary outcome measure

  • Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) [ Time Frame: Baseline to Day 35 ]
  • Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Arizona Pulmonary Specialists Ltd

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

+1 602 271 0832

Principal Investigator:

Akshay Muralidhar

UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868-3298

Contacts

+1 714 456 6037

Principal Investigator:

Bassam Yaghmour

Stanford Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

+1 650 725 5495

Principal Investigator:

Roham Zamanian

Univ Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

+1 720 848 6567

Principal Investigator:

David B Badesch

Central Florida Pulmonary Group

Recruiting

Orlando, Florida, United States, 32803-5734

Contacts

+1 407 841 1100

Principal Investigator:

Syed Mobin

University of South Florida

Recruiting

Tampa, Florida, United States, 33606-3475

Contacts

+1 813 844 7137

Principal Investigator:

Ricardo Restrepo-Jaramillo

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

+1 404 778 3261

Principal Investigator:

Micah Fisher

U of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

+1 913 588 9722

Principal Investigator:

Leslie Spikes

Norton Infectious Diseases Specialists

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

+1 502 587 8000

Principal Investigator:

John Wesley McConnell

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

+1 617 636 4288

Principal Investigator:

Nicholas Hill

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

+1 781 744 3874

Principal Investigator:

Ioana Preston

Sky Integrative Medical Center SKYCRNG PPDS

Recruiting

Ridgeland, Mississippi, United States, 39157-5179

Principal Investigator:

Bob Hutchins

Summit Health Eastside Clinic

Recruiting

Bend, Oregon, United States, 97701

Principal Investigator:

Jeremy Feldman

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212-4756

Principal Investigator:

Hayah Kassis-George

Statcare Pulmonary Consultants

Recruiting

Knoxville, Tennessee, United States, 37919

Contacts

+1 941 924 9800

Principal Investigator:

John Swisher

PPD Development LP

Recruiting

Austin, Texas, United States, 78744

Contacts

+1 512 447 2985

Principal Investigator:

Jia Chang

PPD Development LP

Recruiting

Austin, Texas, United States, 78744

Principal Investigator:

Shawn Searle

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

+1 214 645 6488

Principal Investigator:

Kelly Chin

The University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132-0001

Contacts

+1 801 213 4086

Principal Investigator:

Katharine Clapham

Pul Ass Richmond Inc P A R

Recruiting

Richmond, Virginia, United States, 23230-1709

Contacts

+1 804 288 5945

Principal Investigator:

Shilpa Johri

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • LTP001
  • pulmonary arterial hypertension
  • PAH
  • PVR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-21.