Unknown Heart, Stroke & Blood NIHR-supported project Lungs & Breathing

A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

Funder NIHR (part of DHSC)
Recipient organisation NIHR Royal Free Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Feb 2025 — Ongoing

In plain English

AI plain-English summary

Every three weeks, 160 adults with pulmonary arterial hypertension will receive an injection of the trial drug sotatercept—either dosed to their exact body weight or to a weight range—to see if the simpler method is safe and works as well. This matters because standard PAH treatments manage symptoms but do not target the underlying disease process. Sotatercept blocks a protein called activin that drives blood vessel thickening in the lungs. Currently, nurses must calculate and prepare individual weight-based doses for each patient, which is time-consuming and prone to error. If weight-banded dosing—where patients fall into one of five pre-set dose groups—proves safe and produces similar drug levels in the blood, it could simplify treatment delivery in busy clinics. If successful, this trial could change how sotatercept is administered across the NHS. Weight-banded dosing would reduce preparation time, lower the risk of dosing mistakes, and make it easier to roll out the therapy to more patients. The study also tracks side effects and tolerability over six months, providing safety data needed for wider use. The trial does not test whether sotatercept improves symptoms or survival—that has been shown in earlier studies—but focuses on whether a practical dosing shortcut is safe enough for routine care.

View original technical description
Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH).Standard PAH treatment includes taking medicines that help lower blood pressure in the lungs and improve blood flow through the heart and lungs. Sotatercept is a trial medicine that can be used to treat PAH and is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. Sotatercept can be given with other standard treatments. The dose (amount) of sotatercept is given based on the person’s exact weight (weight-based doses).Researchers want to know if it is safe to give a dose of sotatercept based on the weight range a person is in (weight-banded doses).The goal of the trial is to learn:• What happens to different doses of sotatercept in a person’s body over time when given as weight-banded doses compared to weight-based doses• About the safety of sotatercept and if people tolerate itAbout 160 people with PAH at least 18 years old will be in the trial and:• Have taken standard PAH treatments for at least 3 months before starting the trial• Do not have certain types of heart disease or certain health conditionsEveryone will receive sotatercept as an injection under the skin once every 3 weeks for about 6 months. People will also continue standard PAH treatments.People will be assigned by equal chance to:• Group 1 (weight-based doses) - Dose of sotatercept based on their exact weight.• Group 2 (weight-banded doses) - Put into 1 of 5 groups based on their weight and receive a dose of sotatercept based on the weight group they are in. The dose of sotatercept goes up as the weight groups go up.Both groups will receive a lower first dose of sotatercept and then the dose will slowly increase until the target weight-based or weight-banded dose is reached. Researchers will lower a person’s dose if they cannot tolerate it.People may be in the trial for up to 9 months.

Researchers

Gerry Coghlan (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care (LIGHTRAY)
A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care
A Phase 3, Randomized, Double-blind, Placebo-controlled study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate-and High-risk PAH Patients
A Phase 3, Randomized, Double-Blind, PlaceboControlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality
A Phase 3, Randomized, Double-blind, Placebo controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients- HYPERION

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