NCT04616027 is a Phase 1 clinical trial of PF-06882961 20 mg in Diabetes Mellitus, Type 2, sponsored by Pfizer.

Who is sponsoring NCT04616027?

NCT04616027 is sponsored by Pfizer.

What drugs are being tested in NCT04616027?

Interventions in NCT04616027: PF-06882961 20 mg.

What condition does NCT04616027 study?

NCT04616027 studies Diabetes Mellitus, Type 2, Renal Impairment, Healthy.

Is NCT04616027 still recruiting?

NCT04616027 is currently completed. Last updated 10 May 2024.

Are results published for NCT04616027?

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

Last reviewed 2024-05-10 · How we verify

NCT04616027

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

STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT

Completed Phase 1 Results posted Last updated 10 May 2024

What this trial tests

Phase 1 trial testing PF-06882961 20 mg in Diabetes Mellitus, Type 2 in 42 participants. Completed in 18 February 2022.

Timeline

13 January 2021

Primary endpoint
18 February 2022

18 February 2022

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	42
Start date	13 January 2021
Primary completion	18 February 2022
Estimated completion	18 February 2022
Sites	3 locations across United States

Drugs / interventions tested

PF-06882961 20 mg — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Renal Impairment — all drugs for Renal Impairment →
Healthy — all drugs for Healthy →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2 or Renal Impairment. 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.

Maximum Observed Plasma Concentration (Cmax) of Plasma PF-06882961 Primary · 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

Cmax was the maximum observed plasma concentration and was directly observed from data.

Group	Value	95% CI
Healthy and Normal Renal Function	38.80	± 28
T2DM Normal Renal Function	38.67	± 58
T2DM Mild Renal Impairment	39.19	± 42
T2DM Moderate Renal Impairment	56.68	± 28
T2DM Severe Renal Impairment	39.18	± 50

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-06882961 Primary · 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.

Group	Value	95% CI
Healthy and Normal Renal Function	362.4	± 30
T2DM Normal Renal Function	404.8	± 49
T2DM Mild Renal Impairment	487.0	± 19
T2DM Moderate Renal Impairment	543.2	± 48
T2DM Severe Renal Impairment	408.8	± 46

Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-06882961 Primary · 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.

Group	Value	95% CI
Healthy and Normal Renal Function	359.9	± 30
T2DM Normal Renal Function	399.6	± 50
T2DM Mild Renal Impairment	466.3	± 19
T2DM Moderate Renal Impairment	538.2	± 44
T2DM Severe Renal Impairment	404.8	± 46

Fraction Unbound (fu) of Plasma PF-06882961 Primary · 0 (pre dose), 4 hours (post dose) on Day 1

Fu was defined as fraction of unbound drug in plasma.

Group	Value	95% CI
Healthy and Normal Renal Function	0.01519	± 9
T2DM Normal Renal Function	0.01542	± 15
T2DM Mild Renal Impairment	0.01699	± 14
T2DM Moderate Renal Impairment	0.01861	± 18
T2DM Severe Renal Impairment	0.01960	± 18

Maximum Observed Concentration of Unbound Drug (Cmax,u) of Plasma PF-06882961 Secondary · 0 (pre dose), 4 hours (post dose) on Day 1

Cmax,u was defined as maximum observed concentration of unbound drug.

Group	Value	95% CI
Healthy and Normal Renal Function	0.5896	± 34
T2DM Normal Renal Function	0.5963	± 60
T2DM Mild Renal Impairment	0.6662	± 32
T2DM Moderate Renal Impairment	1.055	± 25
T2DM Severe Renal Impairment	0.7680	± 57

Unbound Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf,u) of Plasma PF-06882961 Secondary · 0 (pre dose), 4 hours (post dose) on Day 1

AUCinf,u was defined as unbound area under the plasma concentration-time profile from time zero extrapolated to infinite time.

Group	Value	95% CI
Healthy and Normal Renal Function	5.505	± 37
T2DM Normal Renal Function	6.246	± 45
T2DM Mild Renal Impairment	7.931	± 16
T2DM Moderate Renal Impairment	10.01	± 31
T2DM Severe Renal Impairment	8.019	± 50

Unbound Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast,u) of Plasma PF-06882961 Secondary · 0 (pre dose), 4 hours (post dose) on Day 1

AUClast,u was defined as unbound area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.

Group	Value	95% CI
Healthy and Normal Renal Function	5.470	± 38
T2DM Normal Renal Function	6.162	± 46
T2DM Mild Renal Impairment	7.922	± 14
T2DM Moderate Renal Impairment	10.01	± 30
T2DM Severe Renal Impairment	7.927	± 50

Apparent Clearance (CL/F) of Plasma PF-06882961 Secondary · 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period.

Group	Value	95% CI
Healthy and Normal Renal Function	55.17	± 30
T2DM Normal Renal Function	49.32	± 49
T2DM Mild Renal Impairment	41.08	± 19
T2DM Moderate Renal Impairment	36.83	± 48
T2DM Severe Renal Impairment	48.93	± 46

Apparent Clearance of Unbound Drug After Oral Administration (CLu/F) of Plasma PF-06882961 Secondary · 0 (pre dose), 4 hours (post dose) on Day 1

CLu/F was defined as apparent clearance of unbound drug.

Group	Value	95% CI
Healthy and Normal Renal Function	3631	± 37
T2DM Normal Renal Function	3200	± 45
T2DM Mild Renal Impairment	2525	± 16
T2DM Moderate Renal Impairment	2000	± 31
T2DM Severe Renal Impairment	2494	± 50

Apparent Volume of Distribution (Vz/F) of Plasma PF-06882961 Secondary · 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

Vz/F was defined as apparent volume of distribution.

Group	Value	95% CI
Healthy and Normal Renal Function	600.8	± 59
T2DM Normal Renal Function	552.3	± 89
T2DM Mild Renal Impairment	372.5	± 38
T2DM Moderate Renal Impairment	438.4	± 85
T2DM Severe Renal Impairment	565.9	± 48

Unbound Vz/F (Vz,u/F) of Plasma PF-06882961 Secondary · 0 (pre dose), 4 hours (post dose) on Day 1

Vz,u/F was defined as apparent volume of distribution of unbound drug.

Group	Value	95% CI
Healthy and Normal Renal Function	39530	± 68
T2DM Normal Renal Function	35810	± 84
T2DM Mild Renal Impairment	22890	± 30
T2DM Moderate Renal Impairment	23800	± 63
T2DM Severe Renal Impairment	28900	± 51

Time of Observed Maximum Plasma Concentration (Tmax) of Plasma PF-06882961 Secondary · 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.

Group	Value	95% CI
Healthy and Normal Renal Function	5.00	3.00 – 8.00
T2DM Normal Renal Function	5.00	5.00 – 8.13
T2DM Mild Renal Impairment	6.00	3.00 – 12.0
T2DM Moderate Renal Impairment	5.50	4.00 – 6.00
T2DM Severe Renal Impairment	5.00	4.00 – 6.00

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Healthy and Normal Renal Function

Serious: 0/8 (0%)

Deaths: 0/8

T2DM Normal Renal Function

Serious: 0/7 (0%)

Deaths: 0/7

T2DM Mild Renal Impairment

Serious: 0/8 (0%)

Deaths: 0/8

T2DM Moderate Renal Impairment

Serious: 0/8 (0%)

Deaths: 0/8

T2DM Severe Renal Impairment

Serious: 0/8 (0%)

Deaths: 0/8

Total

Serious: 0/39 (0%)

Deaths: 0/39

Other adverse events (13 terms — click to expand)

Reaction	System	Healthy and Normal Renal F…	T2DM Normal Renal Function	T2DM Mild Renal Impairment	T2DM Moderate Renal Impair…	T2DM Severe Renal Impairment	Total
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Polyuria	Renal and urinary disorders	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—
SARS-CoV-2 test positive	Investigations	—	—	—	—	—	—
Increased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Polydipsia	Metabolism and nutrition disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04616027 adverse events section.

Sponsor's own description

This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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 recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
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 NCT04616027 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 10 May 2024

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/NCT04616027.

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

NCT04616027

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 recruiting trials for Diabetes Mellitus, Type 2

Other Pfizer trials

Verify against primary sources