TriangleNCT05546476 · OUTCOME
Part A: Change From Baseline in Body Weight at Week 12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Kilogram
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Baseline, Week 12
What was measured
Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max \* dose\^Hill) / (ED 50\^Hill + dose\^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.
Analysis population: Censored analysis set included all evaluable participants. For participants who discontinued study intervention, or received a prohibited procedure or prohibited medication, all observations post-discontinuation, or post-procedure, were censored and treated as missing data. For participants who missed a dose, or received an incomplete dose, all observations post-missed/incomplete dose were censored and treated as missing data.
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 | Source count |
|---|---|
| Part A: Placebo | 45 |
| Part A: Ponsegromab 100 mg | 46 |
| Part A: Ponsegromab 200 mg | 46 |
| Part A: Ponsegromab 400 mg | 50 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Placebo | NA | Not reported | NA | NA | Measure Type = Posterior Median = -0.60 Measure of Dispersion = 90% Credible Interval = -1.50 to 0.24 |
| Part A: Ponsegromab 100 mg | NA | Not reported | NA | NA | Measure Type = Posterior Median = 0.75 Measure of Dispersion = 90% Credible Interval = 0.06 to 1.44 |
| Part A: Ponsegromab 200 mg | NA | Not reported | NA | NA | Measure Type = Posterior Median = 1.48 Measure of Dispersion = 90% Credible Interval = 0.87 to 2.08 |
| Part A: Ponsegromab 400 mg | NA | Not reported | NA | NA | Measure Type = Posterior Median = 2.39 Measure of Dispersion = 90% Credible Interval = 1.49 to 3.34 |
Source statistical analyses
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.34
- group Description
- Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Posterior Median
- param Value
- 1.33
- ci Lower Limit
- 1.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.15
- group Description
- Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Posterior Median
- param Value
- 2.08
- ci Lower Limit
- 1.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 4.34
- group Description
- Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Posterior Median
- param Value
- 3
Complete source fields
- analyses
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.34
- group Description
- Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Posterior Median
- param Value
- 1.33
- ci Lower Limit
- 1.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.15
- group Description
- Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Posterior Median
- param Value
- 2.08
- ci Lower Limit
- 1.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 4.34
- group Description
- Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Posterior Median
- param Value
- 3
- classes
- categories
- measurements
- comment
- Measure Type = Posterior Median = -0.60 Measure of Dispersion = 90% Credible Interval = -1.50 to 0.24
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Measure Type = Posterior Median = 0.75 Measure of Dispersion = 90% Credible Interval = 0.06 to 1.44
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Measure Type = Posterior Median = 1.48 Measure of Dispersion = 90% Credible Interval = 0.87 to 2.08
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Measure Type = Posterior Median = 2.39 Measure of Dispersion = 90% Credible Interval = 1.49 to 3.34
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 46
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 50
- units
- Participants
- description
- Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max \* dose\^Hill) / (ED 50\^Hill + dose\^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.
- 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
- MEDIAN
- population Description
- Censored analysis set included all evaluable participants. For participants who discontinued study intervention, or received a prohibited procedure or prohibited medication, all observations post-discontinuation, or post-procedure, were censored and treated as missing data. For participants who missed a dose, or received an incomplete dose, all observations post-missed/incomplete dose were censored and treated as missing data.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 12
- title
- Part A: Change From Baseline in Body Weight at Week 12
- type
- PRIMARY
- unit Of Measure
- Kilogram
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice