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NCT05546476 · OUTCOME

Part A: Change From Baseline in Functional Assessment of Anorexia-Cachexia Therapy- Anorexia and Cachexia Subscale (FAACT-ACS) at Week 12

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 (prior to dose on Day 1), Week 12

What was measured

FAACT-ACS is a 12-item symptom-specific subscale to measure participants' concerns about their anorexia (appetite) or cachexia (weight) for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-ACS score ranged from 0 to 48. Higher scores are associated with a higher health-related quality of life. FAACT-ACS 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: Placebo30
Part A: Ponsegromab 100 mg27
Part A: Ponsegromab 200 mg33
Part A: Ponsegromab 400 mg27

Reported measurements

Source class 1
Values in Units on a scale · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A: Placebo0.52Not reported-1.602.63Not reported
Part A: Ponsegromab 100 mg4.76Not reported2.546.97Not reported
Part A: Ponsegromab 200 mg1.15Not reported-0.903.20Not reported
Part A: Ponsegromab 400 mg4.63Not reported2.406.85Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    7.28
    group Description
    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
    =0.0114
    param Type
    Difference in LS Mean
    param Value
    4.24
    statistical Method
    MMRM analysis; 1-sided
  2. ci Lower Limit
    -2.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    3.57
    group Description
    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
    =0.3600
    param Type
    Difference in LS Mean
    param Value
    0.64
    statistical Method
    MMRM analysis; 1-sided
  3. ci Lower Limit
    1.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    7.17
    group Description
    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
    =0.0138
    param Type
    Difference in LS Mean
    param Value
    4.11
    statistical Method
    MMRM analysis; 1-sided
Complete source fields
analyses
  1. ci Lower Limit
    1.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    7.28
    group Description
    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
    =0.0114
    param Type
    Difference in LS Mean
    param Value
    4.24
    statistical Method
    MMRM analysis; 1-sided
  2. ci Lower Limit
    -2.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    3.57
    group Description
    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
    =0.3600
    param Type
    Difference in LS Mean
    param Value
    0.64
    statistical Method
    MMRM analysis; 1-sided
  3. ci Lower Limit
    1.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    7.17
    group Description
    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
    =0.0138
    param Type
    Difference in LS Mean
    param Value
    4.11
    statistical Method
    MMRM analysis; 1-sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.60
        upper Limit
        2.63
        value
        0.52
      2. group Id
        OG001
        lower Limit
        2.54
        upper Limit
        6.97
        value
        4.76
      3. group Id
        OG002
        lower Limit
        -0.90
        upper Limit
        3.20
        value
        1.15
      4. group Id
        OG003
        lower Limit
        2.40
        upper Limit
        6.85
        value
        4.63
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      27
    3. group Id
      OG002
      value
      33
    4. group Id
      OG003
      value
      27
    units
    Participants
description
FAACT-ACS is a 12-item symptom-specific subscale to measure participants' concerns about their anorexia (appetite) or cachexia (weight) for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-ACS score ranged from 0 to 48. Higher scores are associated with a higher health-related quality of life. FAACT-ACS 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 (prior to dose on Day 1), Week 12
title
Part A: Change From Baseline in Functional Assessment of Anorexia-Cachexia Therapy- Anorexia and Cachexia Subscale (FAACT-ACS) at Week 12
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice