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OverweightPhase 1NCT05677867

A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese

A Phase 1 study testing Formulation A (PF-07081532 20 mg plus 60 mg) and Formulation B (PF-07081532 80 mg) in people with Overweight and Obesity, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
Formulation A (PF-07081532 20 mg plus 60 mg) and Formulation B (PF-07081532 80 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
18 Jan 2023to 14 Mar 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female participants must be at least 18 years of age, inclusive, at the time of signing the ICD
  • Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
  • A total body weight >50 kg (110 lb) and BMI of 25.0 to <34.9 kg/m2, inclusive, at the screening visit
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or pancreatitis, or participants with suspected MTC per the investigator's judgement
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
Show all 19Show fewer
  • In females, current use of hormone replacement therapy or oral/injectable contraceptives containing ethinyl estradiol
  • Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Investigational products which are strong CYP3A inducers or time-dependent inhibitors are prohibited within 14 days plus 5 half-lives or 30 days (whichever is longer) prior to the dose of study intervention
  • Known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-07081532 or known intolerance to a GLP-1R agonist
  • A positive urine drug test
  • Using a properly sized and calibrated BP cuff, screening supine BP ≥140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility
  • Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
  • Aspartate aminotransferase or alanine aminotransferase level ≥1.25 × upper limit of normal (ULN);
  • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN;
  • HbA1c ≥6.5%;
  • Fasting blood glucose ≥126 mg/dL (7 mmol/L);
  • Calcitonin > ULN;
  • eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF 2 DIFFERENT FORMULATIONS OF PF-07081532 ADMINISTERED ORALLY TO ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR OBESE

The purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. All study participants will receive a total of 2 single doses of this study medication in either form. Form A consists of a PF-07081532 20 mg immediate release tablet and a PF-07081532 60 mg immediate release tablet. Form B consists of a PF-07081532 80 mg immediate release tablet. Each single dose will be separated by a minimum of 6 days. The amount of PF-07081532 in the blood for 4 days after taking each single dose will be compared between the two different formulations of PF-07081532.

The total time that participants will take part in this study is about 70 days. The first visit is a screening visit to ensure that participants are appropriately qualified for the study. This will occur up to 28 days before the first single dose. Participants will be admitted into the clinic one day prior to the first single dose and will remain in the clinic for a total of 11 days. The study team will phone the participants 28 to 35 days after the last dose of study medication.

Conditions
Overweight, Obesity
Being tested
Formulation A (PF-07081532 20 mg plus 60 mg), Formulation B (PF-07081532 80 mg)
Keywords
PF-07081532
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formulation A (PF-07081532 20 mg plus 60 mg)Drug

    Formulation A: administered as a 20 mg immediate release tablet and a 60 mg immediate release tablet

  • Formulation B (PF-07081532 80 mg)Drug

    Formulation B: administered as a 80 mg immediate release tablet

Study groups in NCT05677867
Study groupRoleWhat they receive
Formulation A (Reference) followed by Formulation B (Test)ExperimentalNot described
Receives: Drug: Formulation A (PF-07081532 20 mg plus 60 mg); Drug: Formulation B (PF-07081532 80 mg)
Formulation B (Test) followed by Formulation A (Reference)ExperimentalNot described
Receives: Drug: Formulation A (PF-07081532 20 mg plus 60 mg); Drug: Formulation B (PF-07081532 80 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics Parameter - Area Under the Concentration-Time Curve to Infinity (AUCinf) of PF-07081532

    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.

    Measured: 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

  2. Pharmacokinetics Parameter - Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532

    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.

    Measured: 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

  3. Pharmacokinetics Parameter - Maximum Observed Concentration (Cmax) of PF-07081532

    Cmax is the maximum observed concentration.

    Measured: 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.

Secondary outcomes (4)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related)

    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.

    Measured: From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)

  2. Number of Participants With Laboratory Abnormalities

    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.

    Measured: Baseline (Day 1) up to Period 2 Day 5

  3. Number of Participants Meeting Pre-Specified Criteria of Vital Signs

    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.

    Measured: Baseline (Day 1) up to Period 2 Day 5

  4. Number of Participants Meeting Pre-Specified Criteria of Electrocardiogram (ECGs)

    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.

    Measured: Baseline (Day 1) up to Period 2 Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start18 Jan 2023
  3. Primary completion14 Mar 2023
  4. Study completion14 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
PF-07081532 80 mg will be provided in 2 different oral formulations (A and B). Formulation A will be administered as a PF-07081532 20 mg immediate release tablet and a 60 mg immediate release tablet. Formulation B will be administered as a PF-07081532 80 mg immediate release tablet. The overall design is a randomized, open-label, single dose, 2-period, 2-sequence, crossover study.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05677867
Sponsor's protocol ID
C3991010
Status last verified
Mar 2024
First submitted
13 Dec 2022
Last updated
9 Aug 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Formulation A (PF-07081532 20 mg plus 60 mg) and Formulation B (PF-07081532 80 mg) in people with Overweight and Obesity, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Parameter - Area Under the Concentration-Time Curve to Infinity (AUCinf) of PF-07081532 (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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