Type 2 Diabetes MellitusPhase 1NCT03538743

4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

A Phase 1 study testing PF-06882961 in people with Type 2 Diabetes Mellitus, run by Pfizer at 4 sites in United States.

Completed

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

Trial summary

This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
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: 98 participants
Where: 4 sitesUnited States
Study dates: 25 Jun 2018to 10 Jun 2019
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes treated with a stable dose of metformin at least 500 mg
HbA1c value between 7.0 and 10.5%

Who cannot join

Type 1 diabetes or secondary forms of diabetes

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
Qps-Mra, Llc
South Miami, Florida, 33143
Qps-Mra,Llc
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS

This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.

Conditions: Type 2 Diabetes Mellitus
Being tested: Placebo, PF-06882961
Keywords: Type 2 diabetes mellitus
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.

PlaceboDrug
Tablet, 0 mg, twice daily, 28 days
PF-06882961Drug
Tablet, 15 mg twice daily, 28 days
PF-06882961Drug
Tablet, 50 mg twice daily, 28 days
PF-06882961Drug
Tablet, 150 mg twice daily, 28 days
PF-06882961Drug
Tablet, 300 mg twice daily, 28 days
PF-06882961Drug
Tablet, dose TBD, twice daily, Cohort 5, 28 days
PF-06882961Drug
Tablet, dose TBD, twice daily, Cohort 6, 28 days
PF-06882961Drug
Tablet, dose TBD, twice daily, Cohort 7, 28 days
PF-06882961Drug
Tablet, dose TBD, twice daily, Cohort 8, 28 days

Study groups in NCT03538743
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
PF-06882961 30 mg	Experimental	Not described Receives: Drug: PF-06882961
PF-06882961 100 mg	Experimental	Not described Receives: Drug: PF-06882961
PF-06882961 300 mg	Experimental	Not described Receives: Drug: PF-06882961
PF-06882961 600 mg	Experimental	Not described Receives: Drug: PF-06882961
PF-06882961 dose TBD Cohort 5	Experimental	Not described Receives: Drug: PF-06882961
PF-06882961 dose TBD Cohort 6	Experimental	Not described Receives: Drug: PF-06882961
PF-06882961 dose TBD Cohort 7	Experimental	Not described Receives: Drug: PF-06882961
PF-06882961 dose TBD Cohort 8	Experimental	Not described Receives: Drug: PF-06882961

What is being measured

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

Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Measured: From baseline to up to 35 days after last dose for a total of approximately 63 days
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).
Measured: From baseline to up to 14 days after last dose for a total of approximately 42 days
Number of Participants With Abnormal Vital Signs
Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg.
Measured: From baseline to up to 14 days after last dose for a total of approximately 42 days
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.
1. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.
2. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline
Measured: From baseline to up to 14 days after last dose for a total of approximately 42 days

Secondary outcomes (7)

AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2.
Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours.
Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Terminal Half-life (t½) of PF-06882961 on Day 28
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.
Measured: 0 to 24 hours post-dose on Day 28
Ae24 (%) of PF-06882961 on Day 28
Percent of dose recovered in urine as unchanged drug. Ae24% = 100* Ae24/Dose
Measured: 0 to 24 hours post-dose on Day 28
Renal Clearance (CLr) of PF-06882961 on Day 28
CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.
Measured: 0 to 24 hours post-dose on Day 28

Timeline

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

25 Jun 201810 Jun 2019

First posted29 May 2018
Study start25 Jun 2018
Primary completion23 May 2019
Study completion10 Jun 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03538743
Sponsor's protocol ID: C3421002
Status last verified: Jun 2020
First submitted: 7 May 2018
Last updated: 1 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
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.

Publications

Saxena AR, Gorman DN, Esquejo RM, Bergman A, Chidsey K, Buckeridge C, Griffith DA, Kim AM. Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial. Nat Med. 2021 Jun;27(6):1079-1087. doi: 10.1038/s41591-021-01391-w. Epub 2021 Jun 14.
PubMed 34127852

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
ClinicalTrials.gov ID: NCT03538743
Acronym / sponsor ID: C3421002
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 25 Jun 2018 (actual)
Primary completion: 23 May 2019 (actual)
Study completion: 10 Jun 2019 (actual)
First posted: 29 May 2018 (actual)
Results: Posted 1 Jul 2020

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 dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
PF-06882961 30 mg	Experimental	Drug: PF-06882961
PF-06882961 100 mg	Experimental	Drug: PF-06882961
PF-06882961 300 mg	Experimental	Drug: PF-06882961
PF-06882961 600 mg	Experimental	Drug: PF-06882961
PF-06882961 dose TBD Cohort 5	Experimental	Drug: PF-06882961
PF-06882961 dose TBD Cohort 6	Experimental	Drug: PF-06882961
PF-06882961 dose TBD Cohort 7	Experimental	Drug: PF-06882961
PF-06882961 dose TBD Cohort 8	Experimental	Drug: PF-06882961

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Type 2 diabetes treated with a stable dose of metformin at least 500 mg
HbA1c value between 7.0 and 10.5%

Key exclusion criteria (1 listed)

Type 1 diabetes or secondary forms of diabetes

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
PlaceboTablet, 0 mg, twice daily, 28 days	Drug	Placebo
PF-06882961Tablet, 15 mg twice daily, 28 days	Drug	PF-06882961 30 mg
PF-06882961Tablet, 50 mg twice daily, 28 days	Drug	PF-06882961 100 mg
PF-06882961Tablet, 150 mg twice daily, 28 days	Drug	PF-06882961 300 mg
PF-06882961Tablet, 300 mg twice daily, 28 days	Drug	PF-06882961 600 mg
PF-06882961Tablet, dose TBD, twice daily, Cohort 5, 28 days	Drug	PF-06882961 dose TBD Cohort 5
PF-06882961Tablet, dose TBD, twice daily, Cohort 6, 28 days	Drug	PF-06882961 dose TBD Cohort 6
PF-06882961Tablet, dose TBD, twice daily, Cohort 7, 28 days	Drug	PF-06882961 dose TBD Cohort 7
PF-06882961Tablet, dose TBD, twice daily, Cohort 8, 28 days	Drug	PF-06882961 dose TBD Cohort 8

Primary outcome

Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Time frame: From baseline to up to 35 days after last dose for a total of approximately 63 days
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).
Number of Participants With Abnormal Vital Signs
Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days
Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg.
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days
ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec. 2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline

7 secondary outcomes

AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Terminal Half-life (t½) of PF-06882961 on Day 28
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
Time frame: 0 to 24 hours post-dose on Day 28
Ae24 (%) of PF-06882961 on Day 28
Time frame: 0 to 24 hours post-dose on Day 28
Renal Clearance (CLr) of PF-06882961 on Day 28
Time frame: 0 to 24 hours post-dose on Day 28

Results and safety

Results posted to the registry on 1 Jul 2020, 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	25	25
PF-06882961 10mg BID	9	9
PF-06882961 15mg BID	9	8
PF-06882961 50mg BID	10	8
PF-06882961 70mg BID	9	9
PF-06882961 120mg BID	9	9
PF-06882961 120mg BID Slow Titration (ST)	9	9
PF-06882961 120mg QD	8	8
PF-06882961 200mg QD Controlled Release (CR)	10	7

Primary outcome: Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)

Time frame: From baseline to up to 35 days after last dose for a total of approximately 63 days. Count of participants. Unit: Participants

Measure	Placebo n = 25	PF-06882961 10mg BID n = 9	PF-06882961 15mg BID n = 9	PF-06882961 50mg BID n = 10	PF-06882961 70mg BID n = 9	PF-06882961 120mg BID n = 9	PF-06882961 120mg BID ST n = 9	PF-06882961 120mg QD n = 8	PF-06882961 200mg QD CR n = 10
All-causality AE	17	6	8	10	8	8	9	8	9
All-causality SAE	0	0	0	0	0	0	1	0	0
Treatment-related AE	14	4	4	10	7	8	9	8	9
Treatment-related SAE	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received at least 1 dose of randomized study treatment.

Primary outcome: Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality

Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days. Count of participants. Unit: Participants

Measure	Placebo n = 25	PF-06882961 10mg BID n = 9	PF-06882961 15mg BID n = 9	PF-06882961 50mg BID n = 10	PF-06882961 70mg BID n = 9	PF-06882961 120mg BID n = 9	PF-06882961 120mg BID ST n = 9	PF-06882961 120mg QD n = 8	PF-06882961 200mg QD CR n = 10
Value	24	7	8	10	8	8	9	7	10

Population analysed: All randomized participants who received at least 1 dose of randomized study treatment.

Primary outcome: Number of Participants With Abnormal Vital Signs

Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days. Count of participants. Unit: Participants

Measure	Placebo n = 25	PF-06882961 10mg BID n = 9	PF-06882961 15mg BID n = 9	PF-06882961 50mg BID n = 10	PF-06882961 70mg BID n = 9	PF-06882961 120mg BID n = 9	PF-06882961 120mg BID ST n = 9	PF-06882961 120mg QD n = 8	PF-06882961 200mg QD CR n = 10
Supine SBP <90 mmHg	3	3	2	1	3	0	3	0	1
Supine SBP increase >=30 mmHg	4	0	0	2	3	1	2	2	1
Supine SBP decrease >=30 mmHg	9	2	5	3	5	3	3	5	4
Supine DBP <50 mmHg	1	1	2	1	1	0	2	0	0
Supine DBP increase >=20 mmHg	1	1	1	0	4	1	2	2	1
Supine DBP decrease >=20 mmHg	6	2	1	2	1	3	4	2	3
Supine pulse rate <40 bpm	0	0	0	0	0	0	0	0	0
Supine pulse rate >120 bpm	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received at least 1 dose of randomized study treatment.

Primary outcome: Number of Participants With Abnormal Electrocardiogram (ECG) Interval

Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days. Count of participants. Unit: Participants

Measure	Placebo n = 25	PF-06882961 10mg BID n = 9	PF-06882961 15mg BID n = 9	PF-06882961 120mg BID n = 9
PR interval ≥300 msec	0	0	0	0
%Change in PR interval ≥25/50%	0	0	0	0
QRS duration ≥140 msec	0	0	0	0
%Change in QRS duration ≥50%	0	0	0	0
QTcF interval >450 and ≤480 msec	2	0	1	0
QTcF interval >480 and ≤500 msec	0	0	0	0
QTcF interval >500 msec	0	0	0	0
Change in QTcF interval >30 and ≤60 msec	0	1	0	1

Population analysed: All randomized participants who received at least 1 dose of randomized study treatment.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 35 days after last dose for a total of approximately 63 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 25 (0%)	15 of 25 (60%)	0 of 25
PF-06882961 10mg BID	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
PF-06882961 15mg BID	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
PF-06882961 50mg BID	0 of 10 (0%)	10 of 10 (100%)	0 of 10
PF-06882961 70mg BID	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
PF-06882961 120mg BID	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
PF-06882961 120mg BID ST	1 of 9 (11.1%)	9 of 9 (100%)	0 of 9
PF-06882961 120mg QD	0 of 8 (0%)	8 of 8 (100%)	0 of 8
PF-06882961 200mg QD CR	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34127852Saxena AR, Gorman DN, Esquejo RM, Bergman A, Chidsey K, Buckeridge C, Griffith DA, Kim AM. Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial. Nat Med. 2021 Jun;27(6):1079-1087. doi: 10.1038/s41591-021-01391-w. Epub 2021 Jun 14.
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

4 sites 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 Type 2 Diabetes Mellitus, run by Pfizer at 4 sites 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 2 inclusion and 1 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 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. 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 Jul 2020). 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?

Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) (time frame: From baseline to up to 35 days after last dose for a total of approximately 63 days). 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 NCT03538743, which also lists 1 linked publication.

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 Jul 2020.