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

NCT ID: NCT06649110

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteers, Pulmonary Arterial Hypertension

Keywords

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LTP001 pulmonary arterial hypertension PAH PVR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LTP001 Dose 1

Group Type EXPERIMENTAL

LTP

Intervention Type DRUG

LTP001

LTP001 Dose 2

Group Type EXPERIMENTAL

LTP

Intervention Type DRUG

LTP001

LTP001 Dose 3

Group Type EXPERIMENTAL

LTP

Intervention Type DRUG

LTP001

Placebo

matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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LTP

LTP001

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males and non-child-bearing potential females


-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.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford Medical Center

Stanford, California, United States

Site Status RECRUITING

The Uni of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Norton Infectious Diseases Specialists

Louisville, Kentucky, United States

Site Status RECRUITING

PPD Development LP

Austin, Texas, United States

Site Status RECRUITING

The University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Pul Ass Richmond Inc P A R

Richmond, Virginia, United States

Site Status RECRUITING

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Novartis Investigative Site

New Lambton Heights, New South Wales, Australia

Site Status RECRUITING

Novartis Investigative Site

Riga, , Latvia

Site Status RECRUITING

Novartis Investigative Site

Lisbon, , Portugal

Site Status RECRUITING

Novartis Investigative Site

Bucharest, , Romania

Site Status RECRUITING

Countries

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United States Australia Latvia Portugal Romania

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

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Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Other Identifiers

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CLTP001A12202

Identifier Type: -

Identifier Source: org_study_id