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

NCT04889157 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C3421028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  Baseline up to 14 days after last dose (Day 70)

• Number of Participants With Abnormal Electrocardiogram (ECG)

  Baseline up to 14 days after last dose (Day 70)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  Baseline up to 35 days after last dose (Day 91)

• Number of Participants With Laboratory Abnormalities

  Baseline up to 14 days after last dose (Day 70)

Study Arms (2)

PF-06882961

EXPERIMENTAL

Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg

Drug: PF-06882961

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PF-06882961 DRUG

Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)

PF-06882961

Placebo DRUG

3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100089, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

danuglipron

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: July 7, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)