A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY

NCT04617275 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C3421008GLP-1Ra Ph 2 Titration Study
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 38

Brief Summary

This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity

Conditions

Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity

  An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. Assessments of AE intensity were defined as mild (easily tolerated, causing minimal discomfort and not interfering with daily activities), moderate (causing sufficient discomfort and interferes with normal daily activities) and severe (preventing normal daily activities).

  Baseline through follow-up (Day 112)

Secondary Outcomes (29)

• Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

  Baseline through Visit 10 (Day 91)

• Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria

  Baseline through Visit 10 (Day 91)

• Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria

  Baseline through Visit 10 (Day 91)

• Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  Week 0, 2, 4, 6, 8, 10, 12, 13-14

• Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)

  Week 0, 2, 4, 6, 8, 10, 12, 13-14.

Study Arms (7)

Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM

EXPERIMENTAL

The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 120 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID

Drug: PF-06882961

Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM

EXPERIMENTAL

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID

Drug: PF-06882961

Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM

EXPERIMENTAL

The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 80 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID

Drug: PF-06882961

Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM

EXPERIMENTAL

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID

Drug: PF-06882961

Arm 5 - Placebo in subjects with T2DM and Obesity

PLACEBO COMPARATOR

Matching Placebo tablets taken twice a day (BID)

Other: Placebo

Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM

EXPERIMENTAL

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID

Drug: PF-06882961

Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity

EXPERIMENTAL

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID

Drug: PF-06882961

Interventions

PF-06882961 DRUG

PF-68882961 will be provided as tablets twice a day (BID)

Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM; Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM; Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM; Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM; Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM; Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity

Placebo OTHER

Placebo comparator will be provided as tablets twice daily for 12 weeks

Arm 5 - Placebo in subjects with T2DM and Obesity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.
• History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening (Visit 1).
• Participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary biliary cirrhosis.
• History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years.
• Any lifetime history of a suicide attempt.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Unity Health - Searcy Medical Center

Searcy, Arkansas, 72143, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

Location

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, 91730, United States

Location

California Research Foundation

San Diego, California, 92123-1881, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20011, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

Pines Care Research Center, LLC

Pembroke Pines, Florida, 33024, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Meridian Clinical Research, LLC

Sioux City, Iowa, 51106, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

Nola Care LLC

Metairie, Louisiana, 70006, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Meridian Clinical Research, LLC DBA Regional Clinical Research

Endwell, New York, 13760, United States

Location

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

Cary, North Carolina, 27518, United States

Location

PMG Research of Charlotte, LLC

Charlotte, North Carolina, 28209, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28601, United States

Location

PMG Research of Rocky Mount, LLC - Investigational Product and Mail delivery

Rocky Mount, North Carolina, 27804, United States

Location

PMG Research of Rocky Mount, LLC - Patient Visits

Rocky Mount, North Carolina, 27804, United States

Location

Carolina Research Center, Inc.

Shelby, North Carolina, 28150, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, 15009, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Palmetto Primary Care Physicians (physicals only)

Summerville, South Carolina, 29485, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230, United States

Location

Juno Research, LLC

Houston, Texas, 77074, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Bountiful Internal Medicine

Bountiful, Utah, 84010, United States

Location

Progressive Clinical Research

Bountiful, Utah, 84010, United States

Location

Wade Family Medicine

Bountiful, Utah, 84010, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Related Publications (1)

• Saxena AR, Frias JP, Gorman DN, Lopez RN, Andrawis N, Tsamandouras N, Birnbaum MJ. Tolerability, safety and pharmacodynamics of oral, small-molecule glucagon-like peptide-1 receptor agonist danuglipron for type 2 diabetes: A 12-week, randomized, placebo-controlled, Phase 2 study comparing different dose-escalation schemes. Diabetes Obes Metab. 2023 Oct;25(10):2805-2814. doi: 10.1111/dom.15168. Epub 2023 Jun 13.

  PMID: 37311722 DERIVED

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

danuglipron

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: January 6, 2021
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: December 8, 2022
• Results First Posted: December 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (38)