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NCT05546476 · FLOW

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Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 · Source last updated 2026-06-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Part A: Participants were randomized to receive placebo matching to Ponsegromab subcutaneously (SC) once in every 4 weeks (Q4W) up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG000
    title
    Part A: Placebo/ Part B: Ponsegromab 400 mg
  2. description
    Part A: Participants were randomized to receive Ponsegromab 100 milligrams (mg) SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG001
    title
    Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg
  3. description
    Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG002
    title
    Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg
  4. description
    Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG003
    title
    Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        4
      type
      Global deterioration of health status
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        46
      4. group Id
        FG003
        num Subjects
        50
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        34
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Period 1: Part A
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        7
      type
      Progressive disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Global deterioration of health status
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        5
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Period 2: Part B
recruitment Details
A total of 187 participants were enrolled in this study. This study had 2 parts: Part A and Part B. On completion of Part A, participants had the opportunity to enter open-label extension period Part B (optional).
Complete source fields
groups
  1. description
    Part A: Participants were randomized to receive placebo matching to Ponsegromab subcutaneously (SC) once in every 4 weeks (Q4W) up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG000
    title
    Part A: Placebo/ Part B: Ponsegromab 400 mg
  2. description
    Part A: Participants were randomized to receive Ponsegromab 100 milligrams (mg) SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG001
    title
    Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg
  3. description
    Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG002
    title
    Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg
  4. description
    Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    FG003
    title
    Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        4
      type
      Global deterioration of health status
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        46
      4. group Id
        FG003
        num Subjects
        50
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        34
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Period 1: Part A
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        7
      type
      Progressive disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Global deterioration of health status
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        5
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Period 2: Part B
recruitment Details
A total of 187 participants were enrolled in this study. This study had 2 parts: Part A and Part B. On completion of Part A, participants had the opportunity to enter open-label extension period Part B (optional).

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Preserved source evidence · Not medical advice