Type 2 Diabetes Mellitus (T2DM)Phase 1NCT01923389

Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

A Phase 1 study testing 100 mg PF-05231023 in people with Type 2 Diabetes Mellitus (T2DM), run by Pfizer at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023. Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus (T2DM)
What is being tested?: 100 mg PF-05231023
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 2 sitesUnited States
Study dates: Sep 2013to Dec 2013
Phase: Phase 1
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 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects of non-childbearing potential between the ages of 21 and 70.
Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.

Who cannot join

Recent (6 months) unstable concurrent disease.
History of allergic disease or drug allergies.
Any condition affecting food consumption or absorption.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Pfizer Investigational Site
Orlando, Florida, 32803
Pfizer Investigational Site
Orlando, Florida, 32804

Other trials in United States

About this study

Official title: A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-05231023 In Obese Adult Subjects

This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.

Conditions: Type 2 Diabetes Mellitus (T2DM)
Being tested: Placebo, 100 mg PF-05231023
Keywords: T2DM, obesity, safety, multiple dose, intravenous
Medical subject headings: Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.
100 mg PF-05231023Drug
100 mg IV infusion twice a week for 4 weeks

Study groups in NCT01923389
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Other: Placebo
100 mg PF-05231023	Experimental	Not described Receives: Drug: 100 mg PF-05231023

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.
Measured: Day -7 through the last follow-up (Day 68)
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.
Measured: Days -7 up to the last follow-up (Day 68)
Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern
ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.
Measured: Days -7 up to the last follow-up (Day 68)
Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.
Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.
Measured: Days 1 up to the last follow-up (Day 68)

Secondary outcomes (9)

Number of Participants With Abnormal Clinical Laboratory Measurements
The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Measured: Days -7 up to the last follow-up (Day 68)
Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Days 1 and 25
Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Days 1 and 25
Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Day 25
Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Day 25
Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Day 25
Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Day 25
Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Day 25
Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Measured: Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Dec 2013

First posted15 Aug 2013 (estimated)
Study startSep 2013
Primary completionDec 2013
Study completionDec 2013

Why it stopped: The study was terminated on December 19th, 2013 due to a business decision by the Sponsor. No safety concerns have been observed in this study.

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.
Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01923389
Sponsor's protocol ID: B2901009
Status last verified: Sep 2014
First submitted: 30 Jul 2013
Last updated: 17 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus (T2DM) trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-05231023 In Obese Adult Subjects
ClinicalTrials.gov ID: NCT01923389
Acronym / sponsor ID: B2901009
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: T2DM, obesity, safety, multiple dose, intravenous
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated on December 19th, 2013 due to a business decision by the Sponsor. No safety concerns have been observed in this study.
Enrolment: 4 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 15 Aug 2013 (estimated)
Results: Posted 17 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo
100 mg PF-05231023	Experimental	Drug: 100 mg PF-05231023

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male and female subjects of non-childbearing potential between the ages of 21 and 70.
Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.

Key exclusion criteria (3 listed)

Recent (6 months) unstable concurrent disease.
History of allergic disease or drug allergies.
Any condition affecting food consumption or absorption.

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
Placebo0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.	Other	Placebo
100 mg PF-05231023100 mg IV infusion twice a week for 4 weeks	Drug	100 mg PF-05231023

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Day -7 through the last follow-up (Day 68)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
Time frame: Days -7 up to the last follow-up (Day 68)
Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.
Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern
Time frame: Days -7 up to the last follow-up (Day 68)
ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.
Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.
Time frame: Days 1 up to the last follow-up (Day 68)
Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.

9 secondary outcomes

Number of Participants With Abnormal Clinical Laboratory Measurements
Time frame: Days -7 up to the last follow-up (Day 68)
Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Days 1 and 25
Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Days 1 and 25
Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Day 25
Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Day 25
Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Day 25
Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Day 25
Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Day 25
Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
Time frame: Day 25

Results and safety

Results posted to the registry on 17 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	2	1
PF-05231023 100 mg	2	2

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Day -7 through the last follow-up (Day 68). Number. Unit: Participants

Measure	Placebo n = 2	PF-05231023 100 mg n = 2
Value	2	2

Population analysed: All participants who received at least 1 dose of study medication (PF-05231023 or placebo).

Primary outcome: Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern

Time frame: Days -7 up to the last follow-up (Day 68). Number. Unit: Participants

Measure	Placebo n = 2	PF-05231023 100 mg n = 2
Value	0	0

Population analysed: All participants who received at least 1 dose of study medication (PF-05231023 or placebo).

Primary outcome: Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern

Time frame: Days -7 up to the last follow-up (Day 68). Number. Unit: Participants

Measure	Placebo n = 2	PF-05231023 100 mg n = 2
Value	1	0

Population analysed: All participants who received at least 1 dose of study medication (PF-05231023 or placebo).

Primary outcome: Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.

Time frame: Days 1 up to the last follow-up (Day 68). Number. Unit: Participants

Measure	Placebo n = 2	PF-05231023 100 mg n = 2
Value	0	0

Population analysed: All participants who received at least 1 dose of active study medication (PF-05231023). Neutralizing antibodies were not tested because all participants who received PF-05231023 100 mg tested negative for anti-PF-05231023 antibodies.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day -7 through Day 68 (AEs occurred after first dose of study drug were treatment-emergent). Serious AEs (SAEs) were reported from time that subject provided informed consent until 28 calendar days after last dose of the study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-05231023 100 mg	0 of 2 (0%)	2 of 2 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 100 mg PF-05231023 in people with Type 2 Diabetes Mellitus (T2DM), run by Pfizer at 2 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 17 Sep 2014). 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 Adverse Events (AEs) (time frame: Day -7 through the last follow-up (Day 68)). The study lists 4 primary outcomes in all. 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 NCT01923389.

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 17 Sep 2014.