Diabetes Mellitus, Type 2Phase 1NCT04889157

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus

A Phase 1 study testing PF-06882961 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site in China.

Completed

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

Trial summary

This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication. Read more about this study

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: PF-06882961
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteChina
Study dates: 7 Jul 2021to 17 Feb 2022
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 20 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
HbA1c greater than or equal to 7% and less than or equal to 10.5%
Total body weight >50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m^2

Who cannot join

Any condition possibly affecting drug absorption
Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
Any malignancy not considered cured
Personal or family history of MTC or MEN2, or participants with suspected MTC
Acute pancreatitis or history of chronic pancreatitis

Show all 12Show fewer

Acute gallbladder disease
Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
Clinically relevant ECG abnormalities
Positive urine drug test
Clinical relevant laboratory tests abnormalities

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Third Hospital
Beijing, 100089

Other trials in China

About this study

Official title: AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS

This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.

Conditions: Diabetes Mellitus, Type 2
Being tested: PF-06882961, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

PF-06882961Drug
Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)
PlaceboDrug
3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)

Study groups in NCT04889157
Study group	Role	What they receive
PF-06882961	Experimental	Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg Receives: Drug: PF-06882961
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Measured: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1
Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.
Measured: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Measured: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)
Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Measured: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)

Secondary outcomes (4)

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest and maximum absolute values and maximum changes from baseline from time-matched baseline were evaluated at the investigator's discretion.
Measured: Baseline up to 14 days after last dose (Day 70)
Number of Participants With Abnormal Electrocardiogram (ECG)
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.
Measured: Baseline up to 14 days after last dose (Day 70)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Measured: Baseline up to 35 days after last dose (Day 91)
Number of Participants With Laboratory Abnormalities
Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion.
Measured: Baseline up to 14 days after last dose (Day 70)

Timeline

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

7 Jul 202117 Feb 2022

First posted17 May 2021
Study start7 Jul 2021
Primary completion17 Feb 2022
Study completion17 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04889157
Sponsor's protocol ID: C3421028
Status last verified: Jun 2024
First submitted: 12 May 2021
Last updated: 1 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS
ClinicalTrials.gov ID: NCT04889157
Acronym / sponsor ID: C3421028
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 7 Jul 2021 (actual)
Primary completion: 17 Feb 2022 (actual)
Study completion: 17 Feb 2022 (actual)
First posted: 17 May 2021 (actual)
Results: Posted 1 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PF-06882961	Experimental	Drug: PF-06882961Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
HbA1c greater than or equal to 7% and less than or equal to 10.5%
Total body weight >50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m^2

Key exclusion criteria (12 listed)

Any condition possibly affecting drug absorption
Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
Any malignancy not considered cured
Personal or family history of MTC or MEN2, or participants with suspected MTC

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06882961Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)	Drug	PF-06882961
Placebo3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)	Drug	Placebo

Primary outcome

Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1
Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1
Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.
AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)
AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)
Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.

4 secondary outcomes

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to 14 days after last dose (Day 70)
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: Baseline up to 14 days after last dose (Day 70)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline up to 35 days after last dose (Day 91)
Number of Participants With Laboratory Abnormalities
Time frame: Baseline up to 14 days after last dose (Day 70)

Results and safety

Results posted to the registry on 1 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	5	5
PF-06882961 BID	15	15

Primary outcome: Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1

Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliter (ng*hr/mL)

Measure	PF-06882961 10 mg Single Dose n = 15
Value	287.4 (52)

Population analysed: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.

Primary outcome: Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1

Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliter (ng/mL)

Measure	PF-06882961 BID n = 15
Value	37.37 (39)

Population analysed: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.

Primary outcome: AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961

Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID). Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	PF-06882961 40 mg BID n = 15	PF-06882961 80 mg BID n = 15	PF-06882961 120 mg BID n = 14
Value	1446 (236)	1012 (1414)	984.9 (2327)

Population analysed: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.

Primary outcome: Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961

Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	PF-06882961 40 mg BID n = 15	PF-06882961 80 mg BID n = 15	PF-06882961 120 mg BID n = 14
Value	150.3 (176)	98.92 (1059)	110.5 (3069)

Population analysed: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 35 days after last dose (Day 91). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 5 (0%)	5 of 5 (100%)	0 of 5
PF-06882961 BID	0 of 15 (0%)	14 of 15 (93.3%)	0 of 15

Limitations and caveats (from the sponsor): In this study, a Quality Event was identified upon review of the PK data after the final study database release. This Quality Event was identified as non-compliance to study intervention per retrospective investigation post database release. Due to the Quality Event, the PK results of the study were considered not reliable by the sponsor and should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06882961 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site in China.

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 3 inclusion and 12 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 1 Oct 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 China. 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. Some participants in this study may receive a placebo. 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 1 Oct 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?

Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1 (time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1). The study lists 4 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 NCT04889157.

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 1 Oct 2024.