GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT

A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study to Compare the Pharmacokinetics of PF-06882961 in Adult Participants With Varying Degrees of Hepatic Impairment Relative to Participants Without Hepatic Impairment.

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI 17.5-38

Primary endpoints

•Cmax•Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated•Area Under the Plasma Concentration-Time Profile

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04604496

Org study IDC3421014

Timeline

Milestones

Study first posted2020-10-27actual

Study start2020-12-30actual

Primary completion2022-01-10actual

Study completion2022-01-10actual

Last update posted2024-03-21actual

Results first posted2024-03-21actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male and female participants between the ages of 18 (or the minimum country-specific age of consent if >18) and 70 years, inclusive, at the screening visit:

•Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

•Body mass index (BMI) of 17.5 to 38.0 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at the screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.

Exclusion criteria

•Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening;

•At screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed;

•A positive COVID-19 test at screening;

•A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), 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 prior/concomitant therapies

•Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer);

•Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06882961;

•Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2;

•A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study;

•At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed;

•Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact; 13. History of sensitivity to heparin or heparin-induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections;

•Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;

•Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax)

Time frame:Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	95% CI
Without Hepatic Impairment	23.56	—
Mild Hepatic Impairment	31.37	—
Moderate Hepatic Impairment	51.82	—
Severe Hepatic Impairment	78.73	—

Ratio of adjusted geometric means133.1790% CI81.97 – 216.37

Test: the mild hepatic impairment group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means219.9890% CI135.39 – 357.41

Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means334.2190% CI205.70 – 543.00

Test: the severe hepatic impairment group; Reference: the without hepatic impairment group

Primary/protocol endpoint

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)

Time frame:Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (nghr/mL)	95% CI
Without Hepatic Impairment	193.4	—
Mild Hepatic Impairment	237.3	—
Moderate Hepatic Impairment	546.7	—
Severe Hepatic Impairment	1239	—

Ratio of adjusted geometric means122.7090% CI61.33 – 245.49

Test: the mild hepatic impairment group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means282.7390% CI141.32 – 565.66

Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means640.7890% CI320.27 – 1282.00

Test: the severe hepatic impairment group; Reference: the without hepatic impairment group

Primary/protocol endpoint

Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

Time frame:Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (nghr/mL)	95% CI
Without Hepatic Impairment	191.2	—
Mild Hepatic Impairment	235.0	—
Moderate Hepatic Impairment	542.9	—
Severe Hepatic Impairment	1217	—

Ratio of adjusted geometric means122.8990% CI61.51 – 245.51

Test: the mild hepatic impairment group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means283.8890% CI142.10 – 567.13

Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means636.3290% CI318.51 – 1271.24

Test: the severe hepatic impairment group; Reference: the without hepatic impairment group

Primary/protocol endpoint

Fraction of Unbound Drug in Plasma (fu)

Time frame:Predose (0 hours), and 4 hours post dose on Day 1.

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Without Hepatic Impairment	0.02137	—
Mild Hepatic Impairment	0.01820	—
Moderate Hepatic Impairment	0.02059	—
Severe Hepatic Impairment	0.02889	—

Ratio of adjusted geometric means85.1990% CI63.60 – 114.10

Test: the mild hepatic impairment group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means96.3790% CI71.95 – 129.07

Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group

Ratio of adjusted geometric means135.2090% CI100.94 – 181.10

Test: the severe hepatic impairment group; Reference: the without hepatic impairment group

Secondary/protocol endpoint

Number of Participants Reporting Treatment-emergent Adverse Events (AEs)

Time frame:Baseline to Day 30

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic ImpairmentAll-causality	0	—
Treatment-related	0	—
Mild Hepatic ImpairmentAll-causality	1	—
Treatment-related	1	—
Moderate Hepatic ImpairmentAll-causality	2	—
Treatment-related	2	—
Severe Hepatic ImpairmentAll-causality	1	—
Treatment-related	1	—

Secondary/protocol endpoint

Number of Participants With Clinical Laboratory Abnormalities

Time frame:Baseline to Day 3

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic Impairment	3	—
Mild Hepatic Impairment	4	—
Moderate Hepatic Impairment	5	—
Severe Hepatic Impairment	6	—

Secondary/protocol endpoint

Number of Participants With Categorical Vital Signs Data

Time frame:Baseline to Day 3

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic ImpairmentPulse rate value <40 bpm	0	—
Pulse rate value >120 bpm	0	—
Sitting DBP value <50 mm Hg	0	—
Sitting DBP Change ≥ 20 mm Hg increase	0	—
Sitting DBP Change ≥ 20 mm Hg decrease	0	—
Sitting SBP value <90 mm Hg	0	—
Sitting SBP Change ≥ 30 mm Hg increase	1	—
Sitting SBP Change ≥ 30 mm Hg decrease	0	—
Mild Hepatic ImpairmentPulse rate value <40 bpm	0	—
Pulse rate value >120 bpm	0	—
Sitting DBP value <50 mm Hg	0	—
Sitting DBP Change ≥ 20 mm Hg increase	0	—
Sitting DBP Change ≥ 20 mm Hg decrease	0	—
Sitting SBP value <90 mm Hg	0	—
Sitting SBP Change ≥ 30 mm Hg increase	0	—
Sitting SBP Change ≥ 30 mm Hg decrease	0	—
Moderate Hepatic ImpairmentPulse rate value <40 bpm	0	—
Pulse rate value >120 bpm	0	—
Sitting DBP value <50 mm Hg	0	—
Sitting DBP Change ≥ 20 mm Hg increase	2	—
Sitting DBP Change ≥ 20 mm Hg decrease	0	—
Sitting SBP value <90 mm Hg	0	—
Sitting SBP Change ≥ 30 mm Hg increase	0	—
Sitting SBP Change ≥ 30 mm Hg decrease	0	—
Severe Hepatic ImpairmentPulse rate value <40 bpm	0	—
Pulse rate value >120 bpm	0	—
Sitting DBP value <50 mm Hg	1	—
Sitting DBP Change ≥ 20 mm Hg increase	1	—
Sitting DBP Change ≥ 20 mm Hg decrease	0	—
Sitting SBP value <90 mm Hg	1	—
Sitting SBP Change ≥ 30 mm Hg increase	0	—
Sitting SBP Change ≥ 30 mm Hg decrease	0	—

Secondary/protocol endpoint

Number of Participants With Categorical Electrocardiogram (ECG) Data

Time frame:Baseline to Day 3

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic ImpairmentPR interval ≥300 msec	0	—
%Change in PR interval ≥25/50%	0	—
QRS interval ≥140 msec	0	—
%Change in QRS interval ≥50%	0	—
QTcF interval >450 and ≤480 msec	0	—
QTcF interval >480 and ≤500 msec	0	—
QTcF interval >500 msec	0	—
Change in QTcF interval >30 and ≤60 msec	0	—
Change in QTcF interval >60 msec	0	—
Mild Hepatic ImpairmentPR interval ≥300 msec	0	—
%Change in PR interval ≥25/50%	0	—
QRS interval ≥140 msec	0	—
%Change in QRS interval ≥50%	0	—
QTcF interval >450 and ≤480 msec	1	—
QTcF interval >480 and ≤500 msec	0	—
QTcF interval >500 msec	0	—
Change in QTcF interval >30 and ≤60 msec	0	—
Change in QTcF interval >60 msec	0	—
Moderate Hepatic ImpairmentPR interval ≥300 msec	0	—
%Change in PR interval ≥25/50%	0	—
QRS interval ≥140 msec	0	—
%Change in QRS interval ≥50%	0	—
QTcF interval >450 and ≤480 msec	1	—
QTcF interval >480 and ≤500 msec	0	—
QTcF interval >500 msec	0	—
Change in QTcF interval >30 and ≤60 msec	0	—
Change in QTcF interval >60 msec	0	—
Severe Hepatic ImpairmentPR interval ≥300 msec	0	—
%Change in PR interval ≥25/50%	1	—
QRS interval ≥140 msec	0	—
%Change in QRS interval ≥50%	0	—
QTcF interval >450 and ≤480 msec	3	—
QTcF interval >480 and ≤500 msec	0	—
QTcF interval >500 msec	0	—
Change in QTcF interval >30 and ≤60 msec	0	—
Change in QTcF interval >60 msec	0	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.