NCT05546476 · OUTCOME

Part A: Change From Baseline in Physical Activity 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: Minutes per day
Interval / dispersion: 90% Confidence Interval
Time frame: Baseline, Week 12

What was measured

Physical activity was monitored using accelerometry (wearable digital sensors). Physical activity was categorized as: sedentary activity, non-sedentary physical activity, and moderate to vigorous physical activity. In this outcome measure time for each type of physical activity per day was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using mixed models repeated measures (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

Group	Source count
Part A: Placebo	12
Part A: Ponsegromab 100 mg	17
Part A: Ponsegromab 200 mg	16
Part A: Ponsegromab 400 mg	13

Reported measurements

Time for Sedentary Activity

Values in Minutes per day · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part A: Placebo	-1.42	Not reported	-72.77	69.92	Not reported
Part A: Ponsegromab 100 mg	51.93	Not reported	-9.88	113.75	Not reported
Part A: Ponsegromab 200 mg	-39.33	Not reported	-101.94	23.29	Not reported
Part A: Ponsegromab 400 mg	-3.37	Not reported	-72.89	66.14	Not reported

Time for Non-Sedentary Physical Activity

Values in Minutes per day · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part A: Placebo	-37.73	Not reported	-66.14	-9.32	Not reported
Part A: Ponsegromab 100 mg	0.03	Not reported	-24.88	24.95	Not reported
Part A: Ponsegromab 200 mg	-42.09	Not reported	-67.63	-16.56	Not reported
Part A: Ponsegromab 400 mg	12.11	Not reported	-14.87	39.10	Not reported

Time for Moderate to Vigorous Physical Activity

Values in Minutes per day · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part A: Placebo	-4.45	Not reported	-13.91	5.02	Not reported
Part A: Ponsegromab 100 mg	4.07	Not reported	-4.18	12.32	Not reported
Part A: Ponsegromab 200 mg	0.05	Not reported	-8.29	8.39	Not reported
Part A: Ponsegromab 400 mg	3.67	Not reported	-5.37	12.71	Not reported

Source statistical analyses

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

ci Lower Limit
-40.89
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
147.60
group Description
Sedentary Activity Time: 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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.8260
param Type
Difference in LS Mean
param Value
53.36
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-132.94
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
57.14
group Description
Sedentary Activity Time: 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
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
=0.2540
param Type
Difference in LS Mean
param Value
-37.9
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-101.63
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
97.73
group Description
Sedentary Activity Time: 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
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
=0.4870
param Type
Difference in LS Mean
param Value
-1.95
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
0.07
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
75.46
group Description
Non-Sedentary Activity Time: 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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.0497
param Type
Difference in LS Mean
param Value
37.76
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-42.94
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
34.22
group Description
Non-Sedentary Activity Time: 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
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
=0.5745
param Type
Difference in LS Mean
param Value
-4.36
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
10.62
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
89.08
group Description
Non-Sedentary Activity Time: 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
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
=0.0189
param Type
Difference in LS Mean
param Value
49.85
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-4.00
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
21.03
group Description
Moderate to Vigorous Physical Activity Time: 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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.1302
param Type
Difference in LS Mean
param Value
8.51
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-8.18
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
17.16
group Description
Moderate to Vigorous Physical Activity Time: 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
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
=0.2780
param Type
Difference in LS Mean
param Value
4.49
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-5.01
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
21.23
group Description
Moderate to Vigorous Physical Activity Time: 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
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
=0.1529
param Type
Difference in LS Mean
param Value
8.11
statistical Method
MMRM analysis; 1-sided

Complete source fields

analyses

ci Lower Limit
-40.89
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
147.60
group Description
Sedentary Activity Time: 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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.8260
param Type
Difference in LS Mean
param Value
53.36
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-132.94
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
57.14
group Description
Sedentary Activity Time: 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
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
=0.2540
param Type
Difference in LS Mean
param Value
-37.9
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-101.63
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
97.73
group Description
Sedentary Activity Time: 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
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
=0.4870
param Type
Difference in LS Mean
param Value
-1.95
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
0.07
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
75.46
group Description
Non-Sedentary Activity Time: 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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.0497
param Type
Difference in LS Mean
param Value
37.76
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-42.94
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
34.22
group Description
Non-Sedentary Activity Time: 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
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
=0.5745
param Type
Difference in LS Mean
param Value
-4.36
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
10.62
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
89.08
group Description
Non-Sedentary Activity Time: 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
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
=0.0189
param Type
Difference in LS Mean
param Value
49.85
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-4.00
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
21.03
group Description
Moderate to Vigorous Physical Activity Time: 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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.1302
param Type
Difference in LS Mean
param Value
8.51
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-8.18
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
17.16
group Description
Moderate to Vigorous Physical Activity Time: 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
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
=0.2780
param Type
Difference in LS Mean
param Value
4.49
statistical Method
MMRM analysis; 1-sided
ci Lower Limit
-5.01
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
21.23
group Description
Moderate to Vigorous Physical Activity Time: 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
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
=0.1529
param Type
Difference in LS Mean
param Value
8.11
statistical Method
MMRM analysis; 1-sided

classes

categories
measurements
group Id
OG000
lower Limit
-72.77
upper Limit
69.92
value
-1.42
group Id
OG001
lower Limit
-9.88
upper Limit
113.75
value
51.93
group Id
OG002
lower Limit
-101.94
upper Limit
23.29
value
-39.33
group Id
OG003
lower Limit
-72.89
upper Limit
66.14
value
-3.37
title
Time for Sedentary Activity
categories
measurements
group Id
OG000
lower Limit
-66.14
upper Limit
-9.32
value
-37.73
group Id
OG001
lower Limit
-24.88
upper Limit
24.95
value
0.03
group Id
OG002
lower Limit
-67.63
upper Limit
-16.56
value
-42.09
group Id
OG003
lower Limit
-14.87
upper Limit
39.10
value
12.11
title
Time for Non-Sedentary Physical Activity
categories
measurements
group Id
OG000
lower Limit
-13.91
upper Limit
5.02
value
-4.45
group Id
OG001
lower Limit
-4.18
upper Limit
12.32
value
4.07
group Id
OG002
lower Limit
-8.29
upper Limit
8.39
value
0.05
group Id
OG003
lower Limit
-5.37
upper Limit
12.71
value
3.67
title
Time for Moderate to Vigorous Physical Activity

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
17
group Id
OG002
value
16
group Id
OG003
value
13
units
Participants

description

dispersion Type

90% Confidence Interval

groups

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
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
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
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 Physical Activity at Week 12

type

SECONDARY

unit Of Measure

Minutes per day

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Preserved source evidence · Not medical advice