Diabetes Mellitus Type 2Phase 1NCT04305587

Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

A Phase 1 study testing PF-07081532 and Clopidogrel in people with Diabetes Mellitus Type 2, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: PF-07081532 and Clopidogrel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 2 sitesUnited States
Study dates: 16 Mar 2020to 14 Jul 2021
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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Key Inclusion Criteria for participants enrolling with T2DM:

Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
HbA1c value between 7.0% and 10.5%, inclusive.

Key Exclusion Criterion for participants enrolling with T2DM:

-Type 1 Diabetes or secondary forms of diabetes.

Key Inclusion Criterion for participants enrolling with obesity:

-Obese (as indicated by screening BMI) non-diabetic adults.

Key Exclusion Criterion for participants enrolling with obesity:

--Type 1 or Type 2 Diabetes or secondary forms of diabetes.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Qps-Mra, Llc
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.

Conditions: Diabetes Mellitus Type 2
Being tested: PF-07081532, Placebo, Clopidogrel
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

PF-07081532Drug
Investigational Drug once daily for up to 42 days; multiple ascending dose design.
PlaceboOther
Placebo once daily for up to 42 days.
ClopidogrelDrug
Also called Plavix
Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.

Study groups in NCT04305587
Study group	Role	What they receive
Active Obesity	Experimental	Part B Receives: Other: Placebo; Drug: Clopidogrel
Placebo Obesity	Placebo comparator	Part B Receives: Other: Placebo; Drug: Clopidogrel
Active T2DM	Experimental	Parts A and C Receives: Drug: PF-07081532
Placebo T2DM	Placebo comparator	Parts A and C Receives: Drug: PF-07081532

What is being measured

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

Number of Participants With Treatment Emergent Treatment-Related Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C)
Number of Participants With Laboratory Abnormalities
Participants with laboratory abnormalities with ≥2 occurrences (without regard to baseline abnormality) that met pre-specified criteria were High-density lipoprotein (HDL) Cholesterol <0.8✕ lower limit of normal (LLN); Bicarbonate <0.9✕LLN; Calcitonin>1.0✕upper limit of normal (ULN); Triglycerides >1.3✕ULN; Aspartate Aminotransferase >3.0✕ULN; Low-density lipoprotein (LDL) Cholesterol >1.2✕ULN; Urine Glucose ≥1; Urine Ketones ≥1; Urine Leukocyte Esterase ≥1; Urine Leukocytes ≥20; Urine Hyaline Casts >1; Urine Hemoglobin ≥1; and Urine Nitrite ≥1.
Measured: From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)
Number of Participants With Vital Signs Abnormalities
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure < 90 millimeters of mercury (mmHg), supine systolic blood pressure increase/decrease from baseline ≥ 30mmHg; supine diastolic blood pressure <50 mmHg, supine diastolic blood pressure increase/decrease from baseline ≥ 20mmHg; pulse rate <40 beats per minute (bpm) or >120 bpm.
Measured: From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)
Number of Participants With Abnormal Electrocardiogram (ECG)
The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥ 300 milliseconds (msec), percentage change ≥ 25/50%; QRS duration: value ≥140 msec, percentage change ≥ 50%; QTcF interval: 450 < value ≤ 480 msec, 480 < value ≤ 500 msec, value >500 msec, and 30<change ≤ 60 msec, change >60 msec.
Measured: From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)

Secondary outcomes (7)

Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532
AUC24 is defined as area under the concentration-time profile from time 0 to 24 hours using Linear/Log trapezoidal method.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C
Maximum Observed Plasma Concentration (Cmax) for PF-07081532
Cmax is defined as maximum plasma concentration observed directly from data.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532
Tmax is defined as time for Cmax observed directly from data as time of first occurrence.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C
Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532
t1/2 is defined as the time measured for the plasma concentration to decrease by one half.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Day 28 for Part A, on Day 42 for Part B and Part C
Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532
Ae24 is defined as cumulative amount of drug recovered unchanged in urine over 24 hours using the method of urine concentration * volume of urine.
Measured: Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
Percentage of Ae24 (Ae24%) for PF-07081532
Ae24% is defined as percent of dose recovered unchanged in urine over the 24 hours using the method of 100 * Ae24/Dose
Measured: Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
Renal Clearance (CLr) for PF-07081532
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine over the dosing interval tau (Aetau) divided by area under the concentration time-curve from time 0 to time tau (AUCtau)
Measured: Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)

Timeline

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

16 Mar 202014 Jul 2021

First posted12 Mar 2020
Study start16 Mar 2020
Primary completion14 Jul 2021
Study completion14 Jul 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 Diabetes Mellitus Type 2Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04305587
Sponsor's protocol ID: C3991002
Status last verified: Jun 2023
First submitted: 9 Mar 2020
Last updated: 5 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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

Buckeridge C, Tsamandouras N, Carvajal-Gonzalez S, Brown LS, Hernandez-Illas M, Saxena AR. Once-daily oral small-molecule glucagon-like peptide-1 receptor agonist lotiglipron (PF-07081532) for type 2 diabetes and obesity: Two randomized, placebo-controlled, multiple-ascending-dose Phase 1 studies. Diabetes Obes Metab. 2024 Aug;26(8):3155-3166. doi: 10.1111/dom.15643. Epub 2024 May 16.
PubMed 38751362

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?

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04305587
Acronym / sponsor ID: C3991002
Conditions: Diabetes Mellitus Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 16 Mar 2020 (actual)
Primary completion: 14 Jul 2021 (actual)
Study completion: 14 Jul 2021 (actual)
First posted: 12 Mar 2020 (actual)
Results: Posted 5 Feb 2024

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Active Obesity	Experimental	Other: Placebo, Drug: ClopidogrelPart B
Placebo Obesity	Placebo comparator	Other: Placebo, Drug: ClopidogrelPart B
Active T2DM	Experimental	Drug: PF-07081532Parts A and C
Placebo T2DM	Placebo comparator	Drug: PF-07081532Parts A and C

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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-07081532Investigational Drug once daily for up to 42 days; multiple ascending dose design.	Drug	Active T2DM, Placebo T2DM
PlaceboPlacebo once daily for up to 42 days.	Other	Active Obesity, Placebo Obesity
ClopidogrelAlso: PlavixPart B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.	Drug	Active Obesity, Placebo Obesity

Primary outcome

Number of Participants With Treatment Emergent Treatment-Related Adverse Events
Time frame: From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Laboratory Abnormalities
Time frame: From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)
Participants with laboratory abnormalities with ≥2 occurrences (without regard to baseline abnormality) that met pre-specified criteria were High-density lipoprotein (HDL) Cholesterol <0.8✕ lower limit of normal (LLN); Bicarbonate <0.9✕LLN; Calcitonin>1.0✕upper limit of normal (ULN); Triglycerides >1.3✕ULN; Aspartate Aminotransferase >3.0✕ULN; Low-density lipoprotein (LDL) Cholesterol >1.2✕ULN; Urine Glucose ≥1; Urine Ketones ≥1; Urine Leukocyte Esterase ≥1; Urine Leukocytes ≥20; Urine Hyaline Casts >1; Urine Hemoglobin ≥1; and Urine Nitrite ≥1.
Number of Participants With Vital Signs Abnormalities
Time frame: From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure < 90 millimeters of mercury (mmHg), supine systolic blood pressure increase/decrease from baseline ≥ 30mmHg; supine diastolic blood pressure <50 mmHg, supine diastolic blood pressure increase/decrease from baseline ≥ 20mmHg; pulse rate <40 beats per minute (bpm) or >120 bpm.
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)
The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥ 300 milliseconds (msec), percentage change ≥ 25/50%; QRS duration: value ≥140 msec, percentage change ≥ 50%; QTcF interval: 450 < value ≤ 480 msec, 480 < value ≤ 500 msec, value >500 msec, and 30<change ≤ 60 msec, change >60 msec.

7 secondary outcomes

Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C
Maximum Observed Plasma Concentration (Cmax) for PF-07081532
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C
Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Day 28 for Part A, on Day 42 for Part B and Part C
Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532
Time frame: Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
Percentage of Ae24 (Ae24%) for PF-07081532
Time frame: Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
Renal Clearance (CLr) for PF-07081532
Time frame: Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)

Results and safety

Results posted to the registry on 5 Feb 2024, 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 Part A	9	9
PF-07081532 10 mg Part A	7	7
PF-07081532 30 mg Part A	8	8
PF-07081532 60 mg Part A	8	7
PF-07081532 120 mg Part A	8	8
Placebo Part B	3	3
PF-07081532 180 mg Part B	12	12
Placebo Part C	2	2
PF-07081532 180 mg Part C	9	9

Primary outcome: Number of Participants With Treatment Emergent Treatment-Related Adverse Events

Time frame: From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C). Count of participants. Unit: Participants

Measure	Placebo Part A n = 9	PF-07081532 10 mg Part A n = 7	PF-07081532 30 mg Part A n = 8	PF-07081532 60 mg Part A n = 8	PF-07081532 120 mg Part A n = 8	Placebo Part B n = 3	PF-07081532 180 mg Part B n = 12	Placebo Part C n = 2	PF-07081532 180 mg Part C n = 9
Treatment-related AEs	5	2	6	6	8	2	11	2	9
Treatment-related SAEs	0	0	1	0	0	0	0	0	0

Population analysed: The population for this outcome measure included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Primary outcome: Number of Participants With Laboratory Abnormalities

Time frame: From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C). Count of participants. Unit: Participants

Measure	Placebo Part A n = 8	PF-07081532 10 mg Part A n = 7	PF-07081532 30 mg Part A n = 8	PF-07081532 60 mg Part A n = 8	PF-07081532 120 mg Part A n = 8	Placebo Part B n = 3	PF-07081532 180 mg Part B n = 12	Placebo Part C n = 2	PF-07081532 180 mg Part C n = 9
HDL Cholesterol (mg/dL) <0.8✕LLN	2	0	3	2	1	1	1	1	2
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	1	0	0	0	2	0	0	0	0
Calcitonin (pg/mL) >1.0✕ULN	0	0	0	1	2	0	1	0	0
Triglycerides (mg/dL) >1.3✕ULN	2	0	1	0	0	0	0	0	0
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	0	0	0	0	0	2	0	0
LDL Cholesterol (mg/dL) >1.2✕ULN	1	0	0	0	1	0	2	0	0
Urine Glucose ≥1	3	1	2	2	3	0	0	1	1
Urine Ketones ≥1	0	0	1	1	3	0	3	0	0

Primary outcome: Number of Participants With Vital Signs Abnormalities

Measure	Placebo Part A n = 9	PF-07081532 10 mg Part A n = 7	PF-07081532 30 mg Part A n = 8	PF-07081532 60 mg Part A n = 8	PF-07081532 120 mg Part A n = 8	Placebo Part B n = 3	PF-07081532 180 mg Part B n = 12	Placebo Part C n = 2	PF-07081532 180 mg Part C n = 9
Supine Systolic Blood Pressure (mmHg) - Value <90mmHg	0	1	1	0	0	0	1	0	1
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	0	1	0	2	0	0	3	0	0
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	2	1	2	4	3	0	0	0	2
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	1	2	0	0	0	0	1	0	0
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	1	1	0	1	0	0	3	0	0
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	1	1	1	2	1	0	0	0	0
Pulse Rate (bpm) - Value <40 bpm	0	0	0	0	0	0	0	0	0
Pulse Rate (bpm) - Value >120 bpm

Primary outcome: Number of Participants With Abnormal Electrocardiogram (ECG)

Measure	Placebo Part A n = 9	PF-07081532 10 mg Part A n = 7	PF-07081532 30 mg Part A n = 8	PF-07081532 60 mg Part A n = 8	PF-07081532 180 mg Part B n = 12	PF-07081532 180 mg Part C n = 9
PR Interval (msec) - Value ≥300	0	0	0	0	0	0
PR Interval (msec) - %Change ≥ 25/50%	0	0	0	0	0	0
QRS Duration (msec) - Value ≥140	0	0	1	0	0	0
QRS Duration (msec) - %Change ≥ 50%	0	0	0	0	0	0
QTcF Interval (msec) - 450 < Value ≤ 480	1	2	1	1	0	0
QTcF Interval (msec) - 480 < Value ≤ 500	0	0	0	0	0	0
QTcF Interval (msec) - Value >500	0	0	0	0	0	0
QTcF Interval (msec) -30 < Change ≤ 60	0	0	1	0	2

7 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Placebo Part A	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
PF-07081532 10 mg Part A	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7
PF-07081532 30 mg Part A	1 of 8 (12.5%)	7 of 8 (87.5%)	0 of 8
PF-07081532 60 mg Part A	0 of 8 (0%)	8 of 8 (100%)	0 of 8
PF-07081532 120 mg Part A	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Placebo Part B	0 of 3 (0%)	3 of 3 (100%)	0 of 3
PF-07081532 180 mg Part B	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Placebo Part C	0 of 2 (0%)	2 of 2 (100%)	0 of 2
PF-07081532 180 mg Part C	0 of 9 (0%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38751362Buckeridge C, Tsamandouras N, Carvajal-Gonzalez S, Brown LS, Hernandez-Illas M, Saxena AR. Once-daily oral small-molecule glucagon-like peptide-1 receptor agonist lotiglipron (PF-07081532) for type 2 diabetes and obesity: Two randomized, placebo-controlled, multiple-ascending-dose Phase 1 studies. Diabetes Obes Metab. 2024 Aug;26(8):3155-3166. doi: 10.1111/dom.15643. Epub 2024 May 16.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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

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 PF-07081532 and Clopidogrel in people with Diabetes Mellitus Type 2, 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?

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 5 Feb 2024. 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 5 Feb 2024). 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 Treatment-Related Adverse Events (time frame: From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C)). 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 NCT04305587, 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 5 Feb 2024.