NCT04552470 is a Phase 1 clinical trial of PF-06882961 in Type 2 Diabetes Mellitus, sponsored by Pfizer.

Who is sponsoring NCT04552470?

NCT04552470 is sponsored by Pfizer.

What drugs are being tested in NCT04552470?

Interventions in NCT04552470: Placebo, PF-06882961.

What condition does NCT04552470 study?

NCT04552470 studies Type 2 Diabetes Mellitus.

Is NCT04552470 still recruiting?

NCT04552470 is currently completed. Last updated 11 March 2022.

Are results published for NCT04552470?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-11 · How we verify

NCT04552470

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 11 March 2022

What this trial tests

Phase 1 trial testing Placebo in Type 2 Diabetes Mellitus in 37 participants. Completed in 25 March 2021.

Timeline

26 October 2020

Primary endpoint
25 March 2021

25 March 2021

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	37
Start date	26 October 2020
Primary completion	25 March 2021
Estimated completion	25 March 2021
Sites	1 location across Japan

Drugs / interventions tested

Placebo
PF-06882961 (pf-06882961) — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Pfizer — full company profile →

Who can join

Adults 20 to 70, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment emergent AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absen

Participants with AEs

Group	Value	95% CI
Placebo	3
PF-06882961 40 mg	7
PF-06882961 80 mg	9
PF-06882961 120 mg	9

Participants with SAEs

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Number of Participants With Clinical Laboratory Abnormalities Primary · Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)

Leukocytes (10\^9/liter \[L\]) bilirubin (micromol/L), glucose (millimoles \[mmol\]/L), triacylglycerol lipase (microkatals \[microkat\]/L): greater than (\>) 1.5\*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1\*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits \[mU\]/L): less than (\<) 0.8\*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): \>1.2\*ULN; triglycerides: \>1.3\*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): \>3.0\*ULN; cholesterol (m

Group	Value	95% CI
Placebo	9
PF-06882961 40 mg	10
PF-06882961 80 mg	8
PF-06882961 120 mg	9

Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Primary · Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)

Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP \<90 mmHg, maximum of SBP \>=30 mmHg decrease from baseline and maximum of SBP \>=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP \<50 mmHg, maximum of DBP \>20 mmHg decrease from baseline and maximum of DBP \>=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate \<40 BPM and maximum of

Minimum of absolute SBP <90 mmHg

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Maximum of SBP >=30 mmHg decrease

Group	Value	95% CI
Placebo	1
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	1

Maximum of SBP >=30 mmHg increase

Group	Value	95% CI
Placebo	3
PF-06882961 40 mg	2
PF-06882961 80 mg	3
PF-06882961 120 mg	2

Minimum of absolute DBP <50 mmHg

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Maximum of DBP >=20 mmHg decrease

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Maximum of DBP >=20 mmHg increase

Group	Value	95% CI
Placebo	1
PF-06882961 40 mg	2
PF-06882961 80 mg	3
PF-06882961 120 mg	3

Minimum of absolute pulse rate <40 BPM

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Maximum of absolute pulse rate >120 BPM

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Primary · Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)

PR interval had following categories: maximum absolute PR interval \>=300 milliseconds (msec); when baseline PR interval \>200 msec and maximum increase from baseline in PR interval \>=25 percent; when baseline PR interval less than or equal to (\<=) 200 msec and maximum increase from baseline in PR interval \>=50 percent. QRS interval had following categories: maximum absolute QRS interval \>=140 msec; maximum increase from baseline in QRS interval \>=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval \>450 msec to \<=480 msec; absolut

Maximum absolute PR >=300 msec

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Baseline PR >200 msec and maximum increase in PR >=25%

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Baseline PR <=200 msec and maximum increase in PR >=50%

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Maximum absolute QRS >=140 msec

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Maximum increase in QRS >=50%

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Absolute QTCF interval >450 msec to <=480 msec

Group	Value	95% CI
Placebo	1
PF-06882961 40 mg	0
PF-06882961 80 mg	1
PF-06882961 120 mg	1

Absolute QTCF interval >480 msec to <=500 msec

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Absolute QTCF >500 msec

Group	Value	95% CI
Placebo	0
PF-06882961 40 mg	0
PF-06882961 80 mg	0
PF-06882961 120 mg	0

Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961 Secondary · Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1 and 56

AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).

Day 1

Group	Value	95% CI
PF-06882961 40 mg	414.4	± 58
PF-06882961 80 mg	500.3	± 58
PF-06882961 120 mg	484.5	± 73

Day 56

Group	Value	95% CI
PF-06882961 40 mg	2424	± 45
PF-06882961 80 mg	4691	± 75
PF-06882961 120 mg	6953	± 148

Maximum Plasma Concentration (Cmax) Observed of PF-06882961 Secondary · Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56

Day 1

Group	Value	95% CI
PF-06882961 40 mg	32.83	± 55
PF-06882961 80 mg	45.89	± 52
PF-06882961 120 mg	39.35	± 80

Day 56

Group	Value	95% CI
PF-06882961 40 mg	206.1	± 54
PF-06882961 80 mg	352.2	± 75
PF-06882961 120 mg	551.7	± 153

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961 Secondary · Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56

Day 1

Group	Value	95% CI
PF-06882961 40 mg	12.0	2.00 – 23.8
PF-06882961 80 mg	12.0	1.00 – 12.0
PF-06882961 120 mg	12.0	1.00 – 14.0

Day 56

Group	Value	95% CI
PF-06882961 40 mg	12.0	6.00 – 13.8
PF-06882961 80 mg	12.9	2.00 – 36.0
PF-06882961 120 mg	12.0	0.000 – 13.8

Terminal Phase Half-Life (t1/2) of PF-06882961 Secondary · Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56

t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Group	Value	95% CI
PF-06882961 40 mg	6.373	± 1.7404
PF-06882961 80 mg	5.543	± 0.30827
PF-06882961 120 mg	5.300	± 0.80594

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/9 (0%)

Deaths: 0/9

PF-06882961 40 mg

Serious: 0/10 (0%)

Deaths: 0/10

PF-06882961 80 mg

Serious: 0/9 (0%)

Deaths: 0/9

PF-06882961 120 mg

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (18 terms — click to expand)

Reaction	System	Placebo	PF-06882961 40 mg	PF-06882961 80 mg	PF-06882961 120 mg
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Lipase increased	Investigations	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04552470 adverse events section.

Sponsor's own description

This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Non-peptide agonists and positive allosteric modulators of glucagon-like peptide-1 receptors: Alternative approaches for treatment of Type 2 diabetes.
Malik F, Li Z. · · 2022 · cited 28× · PMID 33724441 · DOI 10.1111/bph.15446
A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron (PF-06882961), an oral small-molecule glucagon-like peptide-1 receptor agonist, in Japanese adults with type 2 diabetes mellitus.
Ono R, Furihata K, Ichikawa Y, Nakazuru Y, et al · · 2023 · cited 26× · PMID 36433713 · DOI 10.1111/dom.14928
Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study.
Buckeridge C, Cobain S, Bays HE, Matsuoka O, et al · · 2025 · cited 8× · PMID 40539310 · DOI 10.1111/dom.16534
Small-Molecule GLP-1 Receptor Agonists: A Promising Pharmacological Approach.
Șeremet OC, Pușcașu C, Andrei C, Nițulescu G, et al · · 2025 · cited 1× · PMID 41303737 · DOI 10.3390/medicina61111902

Verify or expand the search:

Other trials of PF-06882961

Trials testing the same drug.

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NCT04889157 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults Wit · Phase 1 · completed
NCT04617275 — A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABE · Phase 2 · completed
NCT04621227 — Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In · Phase 1 · completed

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

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NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Pfizer trials

Trials by the same sponsor.

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NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04552470 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 11 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04552470.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04552470

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of PF-06882961

Other recruiting trials for Type 2 Diabetes Mellitus

Other Pfizer trials

Verify against primary sources