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NCT05546476 · OUTCOME

Part A: Change From Baseline in Cancer-Related Cachexia Symptom Diary (CRCSD) Scores at Week 12: Appetite, Nausea and Physical Fatigue

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.

Measure
LEAST_SQUARES_MEAN
Unit
Units on a scale
Interval / dispersion
90% Confidence Interval
Time frame
Baseline, Week 12

What was measured

The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue. Participants rated appetite, nausea and physical fatigue symptom every day, and weekly averages were calculated over the 7 days prior, from 0 to 10, where 0 = no symptom and 10 = worst possible symptom. Higher scores indicated more severe disease. CRCSD was analyzed using an MMRM model.

Analysis population: Censored analysis set:all evaluable participants.For participants who discontinued study intervention/received prohibited procedure/ prohibited medication,all observations post-discontinuation/post-procedure,were censored and treated as missing data.For participants who missed dose/received incomplete dose,all observations post-missed/incomplete dose were censored and treated as missing data.''Overall Number of Participants Analyzed'' =participants evaluable for this outcome measure at Week 12.

Groups in this outcome

Part A: Placebo

Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).

Part A: Ponsegromab 100 mg

Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Part A: Ponsegromab 200 mg

Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).

Part A: Ponsegromab 400 mg

Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A: Placebo24
Part A: Ponsegromab 100 mg30
Part A: Ponsegromab 200 mg26
Part A: Ponsegromab 400 mg27

Reported measurements

Appetite
Values in Units on a scale · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A: Placebo-0.23Not reported-0.830.37Not reported
Part A: Ponsegromab 100 mg0.20Not reported-0.360.76Not reported
Part A: Ponsegromab 200 mg0.23Not reported-0.370.82Not reported
Part A: Ponsegromab 400 mg0.69Not reported0.111.27Not reported
Nausea
Values in Units on a scale · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A: Placebo-0.33Not reported-0.820.17Not reported
Part A: Ponsegromab 100 mg0.14Not reported-0.320.61Not reported
Part A: Ponsegromab 200 mg0.06Not reported-0.430.55Not reported
Part A: Ponsegromab 400 mg-0.50Not reported-0.98-0.02Not reported
Physical Fatigue
Values in Units on a scale · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A: Placebo-0.27Not reported-0.850.32Not reported
Part A: Ponsegromab 100 mg0.39Not reported-0.160.94Not reported
Part A: Ponsegromab 200 mg0.38Not reported-0.210.96Not reported
Part A: Ponsegromab 400 mg-0.06Not reported-0.630.51Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.24
    group Description
    Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1912
    param Type
    Difference in LS Mean
    param Value
    0.43
    statistical Method
    MMRM analysis; 1-sided
  2. ci Lower Limit
    -0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.30
    group Description
    Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1866
    param Type
    Difference in LS Mean
    param Value
    0.46
    statistical Method
    MMRM analysis; 1-sided
  3. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.75
    group Description
    Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0349
    param Type
    Difference in LS Mean
    param Value
    0.92
    statistical Method
    MMRM analysis; 1-sided
  4. ci Lower Limit
    -0.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.14
    group Description
    Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.8754
    param Type
    Difference in LS Mean
    param Value
    0.47
    statistical Method
    MMRM analysis; 1-sided
  5. ci Lower Limit
    -0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.08
    group Description
    Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.8205
    param Type
    Difference in LS Mean
    param Value
    0.38
    statistical Method
    MMRM analysis; 1-sided
  6. ci Lower Limit
    -0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    0.51
    group Description
    Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.3375
    param Type
    Difference in LS Mean
    param Value
    -0.17
    statistical Method
    MMRM analysis; 1-sided
  7. ci Lower Limit
    -0.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.45
    group Description
    Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.9138
    param Type
    Difference in LS Mean
    param Value
    0.66
    statistical Method
    MMRM analysis; 1-sided
  8. ci Lower Limit
    -0.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.46
    group Description
    Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.9011
    param Type
    Difference in LS Mean
    param Value
    0.64
    statistical Method
    MMRM analysis; 1-sided
  9. ci Lower Limit
    -0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.02
    group Description
    Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.6618
    param Type
    Difference in LS Mean
    param Value
    0.21
    statistical Method
    MMRM analysis; 1-sided
Complete source fields
analyses
  1. ci Lower Limit
    -0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.24
    group Description
    Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1912
    param Type
    Difference in LS Mean
    param Value
    0.43
    statistical Method
    MMRM analysis; 1-sided
  2. ci Lower Limit
    -0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.30
    group Description
    Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1866
    param Type
    Difference in LS Mean
    param Value
    0.46
    statistical Method
    MMRM analysis; 1-sided
  3. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.75
    group Description
    Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0349
    param Type
    Difference in LS Mean
    param Value
    0.92
    statistical Method
    MMRM analysis; 1-sided
  4. ci Lower Limit
    -0.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.14
    group Description
    Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.8754
    param Type
    Difference in LS Mean
    param Value
    0.47
    statistical Method
    MMRM analysis; 1-sided
  5. ci Lower Limit
    -0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.08
    group Description
    Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.8205
    param Type
    Difference in LS Mean
    param Value
    0.38
    statistical Method
    MMRM analysis; 1-sided
  6. ci Lower Limit
    -0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    0.51
    group Description
    Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.3375
    param Type
    Difference in LS Mean
    param Value
    -0.17
    statistical Method
    MMRM analysis; 1-sided
  7. ci Lower Limit
    -0.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.45
    group Description
    Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.9138
    param Type
    Difference in LS Mean
    param Value
    0.66
    statistical Method
    MMRM analysis; 1-sided
  8. ci Lower Limit
    -0.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.46
    group Description
    Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.9011
    param Type
    Difference in LS Mean
    param Value
    0.64
    statistical Method
    MMRM analysis; 1-sided
  9. ci Lower Limit
    -0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.02
    group Description
    Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.6618
    param Type
    Difference in LS Mean
    param Value
    0.21
    statistical Method
    MMRM analysis; 1-sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.83
        upper Limit
        0.37
        value
        -0.23
      2. group Id
        OG001
        lower Limit
        -0.36
        upper Limit
        0.76
        value
        0.20
      3. group Id
        OG002
        lower Limit
        -0.37
        upper Limit
        0.82
        value
        0.23
      4. group Id
        OG003
        lower Limit
        0.11
        upper Limit
        1.27
        value
        0.69
    title
    Appetite
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.82
        upper Limit
        0.17
        value
        -0.33
      2. group Id
        OG001
        lower Limit
        -0.32
        upper Limit
        0.61
        value
        0.14
      3. group Id
        OG002
        lower Limit
        -0.43
        upper Limit
        0.55
        value
        0.06
      4. group Id
        OG003
        lower Limit
        -0.98
        upper Limit
        -0.02
        value
        -0.50
    title
    Nausea
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.85
        upper Limit
        0.32
        value
        -0.27
      2. group Id
        OG001
        lower Limit
        -0.16
        upper Limit
        0.94
        value
        0.39
      3. group Id
        OG002
        lower Limit
        -0.21
        upper Limit
        0.96
        value
        0.38
      4. group Id
        OG003
        lower Limit
        -0.63
        upper Limit
        0.51
        value
        -0.06
    title
    Physical Fatigue
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      27
    units
    Participants
description
The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue. Participants rated appetite, nausea and physical fatigue symptom every day, and weekly averages were calculated over the 7 days prior, from 0 to 10, where 0 = no symptom and 10 = worst possible symptom. Higher scores indicated more severe disease. CRCSD was analyzed using an MMRM model.
dispersion Type
90% Confidence Interval
groups
  1. description
    Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG000
    title
    Part A: Placebo
  2. description
    Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG001
    title
    Part A: Ponsegromab 100 mg
  3. description
    Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG002
    title
    Part A: Ponsegromab 200 mg
  4. description
    Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG003
    title
    Part A: Ponsegromab 400 mg
param Type
LEAST_SQUARES_MEAN
population Description
Censored analysis set:all evaluable participants.For participants who discontinued study intervention/received prohibited procedure/ prohibited medication,all observations post-discontinuation/post-procedure,were censored and treated as missing data.For participants who missed dose/received incomplete dose,all observations post-missed/incomplete dose were censored and treated as missing data.''Overall Number of Participants Analyzed'' =participants evaluable for this outcome measure at Week 12.
reporting Status
POSTED
time Frame
Baseline, Week 12
title
Part A: Change From Baseline in Cancer-Related Cachexia Symptom Diary (CRCSD) Scores at Week 12: Appetite, Nausea and Physical Fatigue
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice