At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LTP (drug), Placebo (drug)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- LTP — drug: LTP001 · Placebo — drug: Placebo
- Patient visit burden
- Not specified by the sponsor
In plain English
This study tests a medicine called LTP001. Part A involves healthy volunteers, and Part B involves people with pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. The study is run by Novartis Pharmaceuticals.
Who can take part
- Part A: healthy men
- Part A: healthy women who cannot become pregnant
- Part A (Japanese groups only): people must be first, second or third generation Japanese, as set out in the study plan
- Part B: a confirmed diagnosis of PAH
- Part B: a lung blood pressure measure (pulmonary vascular resistance, or PVR) of 400 or more before being placed in a study group
- Part B: already taking standard PAH medicines at steady doses
- Part B: able to walk between 150 and 450 metres in 6 minutes
Who may not be able to
- Part A: significant heart problems found on a heart trace (electrocardiogram, or ECG) or other heart checks
- Part A: any illness or past surgery that might change how the body takes in or clears medicines, or that could make taking part unsafe
- Part B: any illness or past surgery that could make taking part riskier
- Part B: women who could become pregnant, unless they use highly effective contraception
- Part B: sexually active men who will not use a condom during sex while taking the study medicine and for 24 hours after stopping it
- Part B: anyone who has had an allergic reaction to the study medicines or their ingredients
- Other rules in the study plan may also apply to both parts
What taking part involves
- • Taking the study medicine LTP001
- • Part B participants keep taking their usual (standard) PAH medicines at steady doses
- • How LTP001 is given (for example, as a tablet or injection): Not stated — ask the trial team
Time commitment: Not stated — ask the trial team (the number of visits, how long the study lasts, and what taking part involves are not given in this record).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 232
- Started
- 2024-10-24
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for healthy volunteers, pulmonary arterial hypertension
- • Phase1/Phase2 - 232 participants
- • A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with healthy volunteers, pulmonary arterial hypertension
Where?
- • Sheffield - Novartis Investigative Site
- • Cambridge - Novartis Investigative Site
- • London - Novartis Investigative Site
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: All genders
What the study is looking for
- ✓Healthy males and non-child-bearing potential females
- ✓Part A
Who cannot take part
- ✗For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation...
- ✗Part B Inclusion Criteria:
- ✗Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care...
- ✗Part B Exclusion Criteria:
- ✗History of hypersensitivity to any of the study treatments or excipients
See the full criteria
Where Is This Study? (4 UK sites)
Novartis Investigative Site
Sheffield S10 2JF, United Kingdom
Novartis Investigative Site
Cambridge CB2 0AY, United Kingdom
Novartis Investigative Site
London EC1A 7BE, United Kingdom
Novartis Investigative Site
London SW3 6PH, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT