Trial Outcomes & Findings for A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese (NCT NCT05677867)
NCT ID: NCT05677867
Last Updated: 2024-08-09
Results Overview
AUCinf is the area under the concentration-time curve to infinity. AUCinf was calculated by AUClast + (Clast\*/kel), where Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
COMPLETED
PHASE1
20 participants
Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2
2024-08-09
Participant Flow
A total of 20 participants were enrolled and treated in the study. All 20 participants completed the study.
Participant milestones
| Measure |
Sequence 1
Participants in Sequence 1 received a single dose of PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet (Formulation A) on Period 1 Day 1, and then received a single dose of PF-07081532 80 mg immediate release tablet (Formulation B) on Period 2 Day 1, with a minimum washout period of 6 days between the 2 doses.
|
Sequence 2
Participants in Sequence 2 received a single dose of PF-07081532 80 mg immediate release tablet (Formulation B) on Period 1 Day 1, and then received a single dose of PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet (Formulation A) on Period 2 Day 1, with a minimum washout period of 6 days between the 2 doses.
|
|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
10
|
10
|
|
Period 2
COMPLETED
|
10
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
This group includes all participants who enrolled in this study and received at least 1 dose of study intervention.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
42.90 years
STANDARD_DEVIATION 11.04 • n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Body Mass Index
|
28.55 kg/m^2
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2Population: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here "Number of Participants Analyzed" signifies participants who contributed to this outcome measure.
AUCinf is the area under the concentration-time curve to infinity. AUCinf was calculated by AUClast + (Clast\*/kel), where Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Outcome measures
| Measure |
Formulation A
n=17 Participants
Formulation A was administrated as PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=18 Participants
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Pharmacokinetics Parameter - Area Under the Concentration-Time Curve to Infinity (AUCinf) of PF-07081532
|
179400 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
178300 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2Population: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here "Number of Participants Analyzed" signifies participants who contributed to this outcome measure.
AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast was calculated by Linear/Log trapezoidal method.
Outcome measures
| Measure |
Formulation A
n=17 Participants
Formulation A was administrated as PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=18 Participants
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Pharmacokinetics Parameter - Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532
|
171900 ng*hr/mL
Geometric Coefficient of Variation 38
|
170400 ng*hr/mL
Geometric Coefficient of Variation 47
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose of Day 1 Period 1 and Period 2.Population: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here "Number of Participants Analyzed" signifies participants who contributed to this outcome measure.
Cmax is the maximum observed concentration.
Outcome measures
| Measure |
Formulation A
n=17 Participants
Formulation A was administrated as PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=18 Participants
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Pharmacokinetics Parameter - Maximum Observed Concentration (Cmax) of PF-07081532
|
8072 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
7741 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)Population: All participants who take at least 1 dose of study intervention.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Formulation A
n=20 Participants
Formulation A was administrated as PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=20 Participants
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related)
Treatment-Related TEAEs
|
9 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related)
All Causality TEAEs
|
9 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related)
All-Causality Treatment-Emergent SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related)
Treatment-Related Treatment-Emergent SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Period 2 Day 5Population: All participants who took at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants who contributed to this outcome measure.
Participants with laboratory abnormalities that met pre-specified criteria: Urate (millimole/Liter) \> 1.2\*ULN (upper limit of normal) and Monocytes/Leukocytes (%) \> 1.2\*ULN.
Outcome measures
| Measure |
Formulation A
n=10 Participants
Formulation A was administrated as PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=10 Participants
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities
Monocytes/Leukocytes (%) > 1.2*ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urate (mmol/L) > 1.2*ULN
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Period 2 Day 5Population: All participants who took at least 1 dose of study intervention.
Pre-specified criteria of vital signs included: Systolic blood pressure (BP): minimum (min) \<90 mmHg, change from baseline (CfB) maximum (max) decrease or increase \>=30mmHg; Diastolic BP min \<50mmHg, CfB max decrease or increase \>=20mmHg; supine pulse rate: min \< 40 beats per minute (bpm), max \> 120 bpm.
Outcome measures
| Measure |
Formulation A
n=20 Participants
Formulation A was administrated as PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=20 Participants
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Number of Participants Meeting Pre-Specified Criteria of Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Period 2 Day 5Population: All participants who took at least 1 dose of study intervention.
The pre-specified criteria of ECG included: PR interval, aggregated: value \>=300 msec, %change \>= 25/50% msec; QRS duration, aggregated: value\>=200 msec, %changes \>= 25/50% msec; QTCF interval, aggregated: 450\<=value\<480 msec, 480\<=value\<500 msec, value\>=500 msec, 30\<=changes\<60msec, and changes\>=60msec.
Outcome measures
| Measure |
Formulation A
n=20 Participants
Formulation A was administrated as PF-07081532 20 mg immediate release tablet and 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=20 Participants
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Number of Participants Meeting Pre-Specified Criteria of Electrocardiogram (ECGs)
|
0 Participants
|
1 Participants
|
Adverse Events
Formulation A
Formulation B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Formulation A
n=20 participants at risk
Formulation A was administrated as PF-07081532 20 mg immediate release tablet + 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, Participants in Sequence 2 received Formulation A in Period 2.
|
Formulation B
n=20 participants at risk
Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, Participants in Sequence 2 received Formulation B in Period 1.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.0%
1/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
35.0%
7/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
15.0%
3/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.0%
2/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.0%
2/20 • From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER