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NCT03985293

A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

Completed Phase 2 Results posted Last updated 30 June 2022
What this trial tests

Phase 2 trial testing Placebo in Diabetes Mellitus, Type 2 in 412 participants. Completed in 7 July 2021.

Timeline
15 October 2019
Primary endpoint
8 June 2021
7 July 2021

Quick facts

Lead sponsorPfizer
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment412
Start date15 October 2019
Primary completion8 June 2021
Estimated completion7 July 2021
Sites83 locations across Slovakia, Taiwan, Poland, Hungary, South Korea, Canada, Bulgaria, United States

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. 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.

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 Primary · Baseline, Week 16

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

GroupValue95% CI
Placebo-0.02-0.22 – 0.19
PF-06882961 2.5 BID-0.49-0.70 – -0.28
PF-06882961 10 mg BID-0.91-1.11 – -0.72
PF-06882961 40 mg BID-1.03-1.23 – -0.83
PF-06882961 80 mg BID-0.96-1.18 – -0.74
PF-06882961 120 mg BID-1.18-1.41 – -0.95
Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels Secondary · Baseline, Week 16

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

GroupValue95% CI
Placebo7.7
PF-06882961 2.5 BID30.8
PF-06882961 10 mg BID54.1
PF-06882961 40 mg BID58.2
PF-06882961 80 mg BID65.2
PF-06882961 120 mg BID60.5
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 Secondary · Baseline, Week 2

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

GroupValue95% CI
Placebo-0.09-0.17 – -0.01
PF-06882961 2.5 BID-0.18-0.26 – -0.09
PF-06882961 10 mg BID-0.31-0.39 – -0.23
PF-06882961 40 mg BID-0.29-0.37 – -0.21
PF-06882961 80 mg BID-0.33-0.41 – -0.24
PF-06882961 120 mg BID-0.35-0.43 – -0.28
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 Secondary · Baseline, Week 4

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

GroupValue95% CI
Placebo-0.08-0.19 – 0.04
PF-06882961 2.5 BID-0.38-0.50 – -0.26
PF-06882961 10 mg BID-0.51-0.62 – -0.39
PF-06882961 40 mg BID-0.63-0.74 – -0.52
PF-06882961 80 mg BID-0.58-0.70 – -0.46
PF-06882961 120 mg BID-0.64-0.75 – -0.53
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 Secondary · Baseline, Week 6

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

GroupValue95% CI
Placebo-0.07-0.21 – 0.07
PF-06882961 2.5 BID-0.47-0.61 – -0.34
PF-06882961 10 mg BID-0.71-0.84 – -0.57
PF-06882961 40 mg BID-0.84-0.97 – -0.71
PF-06882961 80 mg BID-0.79-0.93 – -0.65
PF-06882961 120 mg BID-0.84-0.98 – -0.71
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 Secondary · Baseline, Week 8

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

GroupValue95% CI
Placebo-0.13-0.29 – 0.03
PF-06882961 2.5 BID-0.50-0.66 – -0.34
PF-06882961 10 mg BID-0.78-0.93 – -0.62
PF-06882961 40 mg BID-0.97-1.13 – -0.82
PF-06882961 80 mg BID-0.92-1.09 – -0.76
PF-06882961 120 mg BID-1.02-1.18 – -0.86
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 Secondary · Baseline, Week 12

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

GroupValue95% CI
Placebo-0.09-0.28 – 0.10
PF-06882961 2.5 BID-0.53-0.72 – -0.34
PF-06882961 10 mg BID-0.88-1.06 – -0.70
PF-06882961 40 mg BID-1.06-1.25 – -0.88
PF-06882961 80 mg BID-0.91-1.12 – -0.71
PF-06882961 120 mg BID-1.11-1.32 – -0.91
Change From Baseline in Fasting Plasma Glucose at Week 2 Secondary · Baseline, Week 2

The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL.

GroupValue95% CI
Placebo-5.58-12.66 – 1.49
PF-06882961 2.5 BID-22.72-29.78 – -15.65
PF-06882961 10 mg BID-21.96-28.91 – -15.01
PF-06882961 40 mg BID-27.79-34.60 – -20.98
PF-06882961 80 mg BID-24.18-31.28 – -17.08
PF-06882961 120 mg BID-30.92-37.66 – -24.17
Change From Baseline in Fasting Plasma Glucose at Week 4 Secondary · Baseline, Week 4

The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.

GroupValue95% CI
Placebo-5.98-13.62 – 1.66
PF-06882961 2.5 BID-17.77-25.46 – -10.09
PF-06882961 10 mg BID-24.66-31.98 – -17.35
PF-06882961 40 mg BID-33.42-40.83 – -26.00
PF-06882961 80 mg BID-33.34-41.25 – -25.44
PF-06882961 120 mg BID-34.06-41.52 – -26.60
Change From Baseline in Fasting Plasma Glucose at Week 6 Secondary · Baseline, Week 6

The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.

GroupValue95% CI
Placebo-0.88-8.62 – 6.86
PF-06882961 2.5 BID-16.78-24.67 – -8.89
PF-06882961 10 mg BID-26.41-33.88 – -18.94
PF-06882961 40 mg BID-30.89-38.47 – -23.30
PF-06882961 80 mg BID-28.36-36.51 – -20.21
PF-06882961 120 mg BID-32.65-40.44 – -24.87
Change From Baseline in Fasting Plasma Glucose at Week 8 Secondary · Baseline, Week 8

The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.

GroupValue95% CI
Placebo-9.10-16.80 – -1.41
PF-06882961 2.5 BID-12.73-20.53 – -4.93
PF-06882961 10 mg BID-26.23-33.57 – -18.89
PF-06882961 40 mg BID-29.74-37.26 – -22.23
PF-06882961 80 mg BID-33.22-41.36 – -25.09
PF-06882961 120 mg BID-34.31-42.46 – -26.16
Change From Baseline in Fasting Plasma Glucose at Week 12 Secondary · Baseline, Week 12

The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.

GroupValue95% CI
Placebo1.21-7.93 – 10.35
PF-06882961 2.5 BID-6.49-15.70 – 2.73
PF-06882961 10 mg BID-22.56-31.17 – -13.95
PF-06882961 40 mg BID-32.01-40.89 – -23.14
PF-06882961 80 mg BID-30.45-40.26 – -20.64
PF-06882961 120 mg BID-32.38-42.83 – -21.94

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Week 21. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 1/66 (2%)
Deaths: 0/66
PF-06882961 2.5mg BID
Serious: 1/68 (1%)
Deaths: 1/68
PF-06882961 10mg BID
Serious: 2/68 (3%)
Deaths: 0/68
PF-06882961 40mg BID
Serious: 6/71 (8%)
Deaths: 2/71
PF-06882961 80mg BID
Serious: 2/67 (3%)
Deaths: 0/67
PF-06882961 120mg BID
Serious: 1/71 (1%)
Deaths: 0/71

Serious adverse events (15 terms)

ReactionSystemPlaceboPF-06882961 2.5mg BIDPF-06882961 10mg BIDPF-06882961 40mg BIDPF-06882961 80mg BIDPF-06882961 120mg BID
AnaemiaBlood and lymphatic system disorders——————
Acute myocardial infarctionCardiac disorders——————
PalpitationsCardiac disorders——————
Cholecystitis acuteHepatobiliary disorders——————
Drug-induced liver injuryHepatobiliary disorders——————
COVID-19 pneumoniaInfections and infestations——————
PneumoniaInfections and infestations——————
Ankle fractureInjury, poisoning and procedural complications——————
SeromaInjury, poisoning and procedural complications——————
Gamma-glutamyltransferase increasedInvestigations——————
SARS-CoV-2 test positiveInvestigations——————
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)——————
Multiple sclerosisNervous system disorders——————
ParaesthesiaNervous system disorders——————
HypertensionVascular disorders——————
Other adverse events (14 terms — click to expand)

ReactionSystemPlaceboPF-06882961 2.5mg BIDPF-06882961 10mg BIDPF-06882961 40mg BIDPF-06882961 80mg BIDPF-06882961 120mg BID
NauseaGastrointestinal disorders——————
VomitingGastrointestinal disorders——————
DiarrhoeaGastrointestinal disorders——————
DyspepsiaGastrointestinal disorders——————
HeadacheNervous system disorders——————
HyperglycaemiaMetabolism and nutrition disorders——————
HypoglycaemiaMetabolism and nutrition disorders——————
Gastrooesophageal reflux diseaseGastrointestinal disorders——————
Urinary tract infectionInfections and infestations——————
Decreased appetiteMetabolism and nutrition disorders——————
DizzinessNervous system disorders——————
Abdominal distensionGastrointestinal disorders——————
SARS-CoV-2 test positiveInvestigations——————
HypertensionVascular disorders——————

Most-reported serious reactions: Anaemia, Acute myocardial infarction, Palpitations, Cholecystitis acute, Drug-induced liver injury, COVID-19 pneumonia, Pneumonia, Ankle fracture.

Data from ClinicalTrials.gov NCT03985293 adverse events section.

Sponsor's own description

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Anti-obesity drug discovery: advances and challenges.
    Müller TD, Blüher M, Tschöp MH, DiMarchi RD. · · 2022 · cited 655× · PMID 34815532 · DOI 10.1038/s41573-021-00337-8
  2. Signaling pathways in obesity: mechanisms and therapeutic interventions.
    Wen X, Zhang B, Wu B, Xiao H, et al · · 2022 · cited 245× · PMID 36031641 · DOI 10.1038/s41392-022-01149-x
  3. Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial.
    Saxena AR, Frias JP, Brown LS, Gorman DN, et al · · 2023 · cited 96× · PMID 37213102 · DOI 10.1001/jamanetworkopen.2023.14493
  4. Cryo-electron microscopy-based drug design.
    Cebi E, Lee J, Subramani VK, Bak N, et al · · 2024 · cited 15× · PMID 38501110 · DOI 10.3389/fmolb.2024.1342179
  5. Applications of oxetanes in drug discovery and medicinal chemistry.
    Huang G, Hucek D, Cierpicki T, Grembecka J. · · 2023 · cited 15× · PMID 37713805 · DOI 10.1016/j.ejmech.2023.115802
  6. Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study.
    Buckeridge C, Cobain S, Bays HE, Matsuoka O, et al · · 2025 · cited 8× · PMID 40539310 · DOI 10.1111/dom.16534
  7. 58<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
    · 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w
  8. Current Perspectives on GLP-1 Agonists in Contemporary Clinical Practice from Science and Mechanistic Foundations To Optimal Translation.
    Abu-Nejim H, Becker RC. · · 2025 · cited 2× · PMID 41065947 · DOI 10.1007/s11883-025-01350-7

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Trials testing the same drug.

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