Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

A 12 week double blind study to evaluate the efficacy, safety and tolerability of

ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab

or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two

injections. Part B is an optional open-label treatment period consisting of ponsegromab

administered every 4 weeks subcutaneously for up to one year. Part B does not include

placebo.

Assessments include:

- Body weight measurements

- Measure the impact of ponsegromab compared to placebo on physical activity.

- Measure the impact of ponsegromab compared to placebo on appetite, fatigue, nausea,

vomiting and physical function questionnaires.

- Blood samples to evaluate safety and additional endpoints including the amount of

study drug in the blood and the effects of the study drug on levels of GDF15

- Up to 3 additional blood samples (two samples during Part A and one sample during

Part B, if relevant) in a subset of participants as part of a substudy for more

comprehensive assessment of the amount of study drug in the blood and of the effects

of the study drug on levels of GDF-15.