Adults 18 to 70, any sex, with Type 2 Diabetes Mellitus. 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.
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse EventsPrimary· Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) o
All-causality AE
Group
Value
95% CI
Placebo SC (SAD Cohorts)
5
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
3
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
3
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
5
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
5
Placebo IV (SAD Cohorts)
0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
3
Placebo SC (MAD Cohorts)
4
PF-06293620 50 mg SC (MAD Cohorts)
4
PF-06293620 75 mg SC (MAD Cohorts)
11
PF-06293620 150 mg SC (MAD Cohorts)
8
All-causality SAE
Group
Value
95% CI
Placebo SC (SAD Cohorts)
0
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
1
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
0
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
0
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
0
Placebo IV (SAD Cohorts)
0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
0
Placebo SC (MAD Cohorts)
0
PF-06293620 50 mg SC (MAD Cohorts)
0
PF-06293620 75 mg SC (MAD Cohorts)
1
PF-06293620 150 mg SC (MAD Cohorts)
2
Treatment-related AE
Group
Value
95% CI
Placebo SC (SAD Cohorts)
1
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
0
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
0
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
3
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
3
Placebo IV (SAD Cohorts)
0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
1
Placebo SC (MAD Cohorts)
1
PF-06293620 50 mg SC (MAD Cohorts)
1
PF-06293620 75 mg SC (MAD Cohorts)
4
PF-06293620 150 mg SC (MAD Cohorts)
5
Treatment-related SAE
Group
Value
95% CI
Placebo SC (SAD Cohorts)
0
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
0
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
0
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
0
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
0
Placebo IV (SAD Cohorts)
0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
0
Placebo SC (MAD Cohorts)
0
PF-06293620 50 mg SC (MAD Cohorts)
0
PF-06293620 75 mg SC (MAD Cohorts)
0
PF-06293620 150 mg SC (MAD Cohorts)
0
Number of Participants With Positive Anti-drug Antibody (ADA) ResultPrimary· Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.88 was considered positive.
Group
Value
95% CI
Placebo SC (SAD Cohorts)
1
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
5
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
2
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
1
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
2
Placebo IV (SAD Cohorts)
0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
1
Placebo SC (MAD Cohorts)
0
PF-06293620 50 mg SC (MAD Cohorts)
5
PF-06293620 75 mg SC (MAD Cohorts)
7
PF-06293620 150 mg SC (MAD Cohorts)
4
Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
AUCinf was calculated as AUClast +(Clast\*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
300
± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
1716
± 46
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
6306
± 54
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
19440
± 56
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
6775
± 12
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
12.00
± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
22.24
± 45
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
23.79
± 47
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
36.13
± 49
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
67.94
± 16
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
128.3
± 54
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
1619
± 46
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
5945
± 53
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
18080
± 58
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
6509
± 13
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
4.779
± 58
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
21.01
± 44
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
22.47
± 47
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
33.59
± 50
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
65.26
± 18
Clearance (CL) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
Group
Value
95% CI
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
14.72
± 16
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
83.20
± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
44.93
± 45
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
42.05
± 47
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
27.67
± 49
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
0.3907
± 58
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
2.896
± 48
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
7.222
± 52
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
22.30
± 62
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
27.64
± 20
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
168
71.9 – 336
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
168
48.0 – 504
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
252
95.9 – 504
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
168
96.0 – 504
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
1.00
1.00 – 2.00
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL\*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
Group
Value
95% CI
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
7.095
1.00 – 2.00
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)Secondary· Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf\*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
Group
Value
95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
21.10
± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
16.25
± 43
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
20.63
± 44
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
18.17
± 48
Adverse events — posted to ClinicalTrials.gov
Time frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes
· Phase 3
· recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus
· recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With
· Phase 1
· recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes
· NA
· active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic
· recruiting
Other Pfizer trials
Trials by the same sponsor.
NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna®
· not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market
· not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea
· not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta
· Phase 1
· not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 16 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02211261.