DiabetesPhase 2NCT04617275
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
A Phase 2 study testing PF-06882961 in people with Diabetes and Obesity, run by Pfizer at 38 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- PF-06882961
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 38 sitesUnited States
- Study dates
- 6 Jan 2021to 17 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).
Who cannot join
- 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.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009
Bountiful Internal Medicine
Bountiful, Utah, 84010
Progressive Clinical Research
Bountiful, Utah, 84010
Wade Family Medicine
Bountiful, Utah, 84010
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209
Clinical Research Professionals
Chesterfield, Missouri, 63005
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Dallas Diabetes Research Center
Dallas, Texas, 75230
Meridian Clinical Research, LLC DBA Regional Clinical Research
Endwell, New York, 13760
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601
Juno Research, LLC
Houston, Texas, 77074
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Manassas Clinical Research Center
Manassas, Virginia, 20110
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Solaris Clinical Research
Meridian, Idaho, 83646
Nola Care LLC
Metairie, Louisiana, 70006
Acevedo Clinical Research Associates
Miami, Florida, 33142
Catalina Research Institute, LLC
Montclair, California, 91763
Research Integrity, LLC
Owensboro, Kentucky, 42303
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
Pines Care Research Center, LLC
Pembroke Pines, Florida, 33024
Arizona Research Center
Phoenix, Arizona, 85053
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730
PMG Research of Rocky Mount, LLC - Investigational Product and Mail delivery
Rocky Mount, North Carolina, 27804
PMG Research of Rocky Mount, LLC - Patient Visits
Rocky Mount, North Carolina, 27804
California Research Foundation
San Diego, California, 92123-1881
Unity Health - Searcy Medical Center
Searcy, Arkansas, 72143
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Carolina Research Center, Inc.
Shelby, North Carolina, 28150
Meridian Clinical Research, LLC
Sioux City, Iowa, 51106
Palmetto Clinical Research
Summerville, South Carolina, 29485
Palmetto Primary Care Physicians (physicals only)
Summerville, South Carolina, 29485
University Clinical Investigators, Inc.
Tustin, California, 92780
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20011
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY
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
- Being tested
- PF-06882961, Placebo
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06882961Drug
PF-68882961 will be provided as tablets twice a day (BID)
PlaceboOther
Placebo comparator will be provided as tablets twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: PF-06882961 |
| Arm 5 - Placebo in subjects with T2DM and Obesity | Placebo comparator | Matching Placebo tablets taken twice a day (BID) Receives: 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 Receives: 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 Receives: Drug: PF-06882961 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline through follow-up (Day 112)
Secondary outcomes (29)
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.
Measured: Baseline through Visit 10 (Day 91)
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Vital signs abnormality criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP >=30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >=20 mmHg.
Measured: Baseline through Visit 10 (Day 91)
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
ECG assessments included pulse rate (PR), QT, heart rate, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value >= 300 msec, or baseline (BL) >200 msec and >=25% increase from BL, or BL <=200 msec and >=50% increase from BL; QRS interval value >= 140msec, or >=50% increase from BL; QTcF value >450 and <=480 msec, or >480 and <=500 msec, or >500 msec, or increase from BL>30 and <=60 msec, or >60msec.
Measured: Baseline through Visit 10 (Day 91)
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Participants who responded "yes" to the questions will be counted. Data relevant to the assessment of suicidality were mapped to the Columbia-Classification Algorithm of Suicide Assessment (C-CASA) codes.
Measured: Week 0, 2, 4, 6, 8, 10, 12, 13-14
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 were completed by participants and reviewed by site staff at the pre-defined time points.
Measured: Week 0, 2, 4, 6, 8, 10, 12, 13-14.
Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 2
CFB in Fasting Plasma Glucose at Week 4
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 4
CFB in Fasting Plasma Glucose at Week 6
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 6
CFB in Fasting Plasma Glucose at Week 8
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 8
CFB in Fasting Plasma Glucose at Week 10
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 10
CFB in Fasting Plasma Glucose at Week 12
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 12
CFB in Glycolated Hemoglobin A1c (HbA1c) at Week 2
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 2
CFB in Glycolated HbA1c at Week 4
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 4
CFB in Glycolated HbA1c at Week 6
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 6
CFB in Glycolated HbA1c at Week 8
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 8
CFB in Glycolated HbA1c at Week 10
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 10
CFB in Glycolated HbA1c at Week 12
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Measured: Baseline, Week 12
CFB in Body Weight at Week 2 (Participants With T2DM)
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Measured: Baseline, Week 2
CFB in Body Weight at Week 4 (Participants With T2DM)
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Measured: Baseline, Week 4
CFB in Body Weight at Week 6 (Participants With T2DM)
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Measured: Baseline, Week 6
CFB in Body Weight at Week 8 (Participants With T2DM)
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Measured: Baseline, Week 8
CFB in Body Weight at Week 10 (Participants With T2DM)
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Measured: Baseline, Week 10
CFB in Body Weight at Week 12 (Participants With T2DM)
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Measured: Baseline, Week 12
CFB in Body Weight at Week 2 (Non-diabetic Participants With Obesity)
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Measured: Baseline, Week 2
CFB in Body Weight at Week 4 (Non-diabetic Participants With Obesity)
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Measured: Baseline, Week 4
CFB in Body Weight at Week 6 (Non-diabetic Participants With Obesity)
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Measured: Baseline, Week 6
CFB in Body Weight at Week 8 (Non-diabetic Participants With Obesity)
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Measured: Baseline, Week 8
CFB in Body Weight at Week 10 (Non-diabetic Participants With Obesity)
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Measured: Baseline, Week 10
CFB in Body Weight at Week 12 (Non-diabetic Participants With Obesity)
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start6 Jan 2021
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617275
- Sponsor's protocol ID
- C3421008
- Other IDs
- GLP-1Ra Ph 2 Titration Study
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2020
- Last updated
- 8 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
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.
PubMed 37311722
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY
- ClinicalTrials.gov ID
- NCT04617275
- Acronym / sponsor ID
- C3421008
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 8 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM | Experimental | Drug: PF-06882961The 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 |
| Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM | Experimental | Drug: PF-06882961The 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 |
| Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM | Experimental | Drug: PF-06882961The 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 |
| Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM | Experimental | Drug: PF-06882961The 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 |
| Arm 5 - Placebo in subjects with T2DM and Obesity | Placebo comparator | Other: PlaceboMatching Placebo tablets taken twice a day (BID) |
| Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM | Experimental | Drug: PF-06882961The 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 |
| Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity | Experimental | Drug: PF-06882961The 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06882961PF-68882961 will be provided as tablets twice a day (BID) | Drug | 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 |
| PlaceboPlacebo comparator will be provided as tablets twice daily for 12 weeks | Other | Arm 5 - Placebo in subjects with T2DM and Obesity |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Time frame: Baseline through follow-up (Day 112)
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).
29 secondary outcomes
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Time frame: Baseline through Visit 10 (Day 91)
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Time frame: Baseline through Visit 10 (Day 91)
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame: Baseline through Visit 10 (Day 91)
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Week 0, 2, 4, 6, 8, 10, 12, 13-14
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week 0, 2, 4, 6, 8, 10, 12, 13-14.
Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2
Time frame: Baseline, Week 2
CFB in Fasting Plasma Glucose at Week 4
Time frame: Baseline, Week 4
CFB in Fasting Plasma Glucose at Week 6
Time frame: Baseline, Week 6
CFB in Fasting Plasma Glucose at Week 8
Time frame: Baseline, Week 8
CFB in Fasting Plasma Glucose at Week 10
Time frame: Baseline, Week 10
CFB in Fasting Plasma Glucose at Week 12
Time frame: Baseline, Week 12
CFB in Glycolated Hemoglobin A1c (HbA1c) at Week 2
Time frame: Baseline, Week 2
CFB in Glycolated HbA1c at Week 4
Time frame: Baseline, Week 4
CFB in Glycolated HbA1c at Week 6
Time frame: Baseline, Week 6
CFB in Glycolated HbA1c at Week 8
Time frame: Baseline, Week 8
CFB in Glycolated HbA1c at Week 10
Time frame: Baseline, Week 10
CFB in Glycolated HbA1c at Week 12
Time frame: Baseline, Week 12
CFB in Body Weight at Week 2 (Participants With T2DM)
Time frame: Baseline, Week 2
CFB in Body Weight at Week 4 (Participants With T2DM)
Time frame: Baseline, Week 4
CFB in Body Weight at Week 6 (Participants With T2DM)
Time frame: Baseline, Week 6
CFB in Body Weight at Week 8 (Participants With T2DM)
Time frame: Baseline, Week 8
CFB in Body Weight at Week 10 (Participants With T2DM)
Time frame: Baseline, Week 10
CFB in Body Weight at Week 12 (Participants With T2DM)
Time frame: Baseline, Week 12
CFB in Body Weight at Week 2 (Non-diabetic Participants With Obesity)
Time frame: Baseline, Week 2
CFB in Body Weight at Week 4 (Non-diabetic Participants With Obesity)
Time frame: Baseline, Week 4
CFB in Body Weight at Week 6 (Non-diabetic Participants With Obesity)
Time frame: Baseline, Week 6
CFB in Body Weight at Week 8 (Non-diabetic Participants With Obesity)
Time frame: Baseline, Week 8
CFB in Body Weight at Week 10 (Non-diabetic Participants With Obesity)
Time frame: Baseline, Week 10
CFB in Body Weight at Week 12 (Non-diabetic Participants With Obesity)
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37311722Saxena 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-06882961 in people with Diabetes and Obesity, run by Pfizer at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity (time frame: Baseline through follow-up (Day 112)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.