Type 2 Diabetes MellitusPhase 1NCT05158244

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

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

Completed

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

Trial summary

This is a Phase 1, randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open study of PF-07081532. Study participants will receive the investigational product or placebo every day for 42 days. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: PF-07081532
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 22 Dec 2021to 15 Jun 2022
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Females of non childbearing potential;
Patients with T2DM, inadequately controlled with metformin;
HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c <6.5% (for non-diabetic obese, if enrolled)
Total body weight >50 kg (110 lbs)
BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI >30.5 to ≤45.5 kg/m2 (for non-diabetic obese)

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease;
Medical history of T2DM (for non-diabetic obese participants, if enrolled);
Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
Evidence or history of clinically significant cardiovascular disease;
Any malignancy not considered cured;
Acute pancreatitis or history of chronic pancreatitis;

Show all 31Show fewer

Acute gallbladder disease;
Any condition possibly affecting drug absorption;
Personal or family history of MTC or MEN2;
Medical or psychiatric condition that may increase the risk of study participation;
Any vaccination within the 1 week prior to admission to the CRU;
Previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose;
Known prior participation in a trial involving PF-07081532;
A positive urine drug screen at screening or admission;
Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb;
Positive COVID-19 test at screening or admission;
Supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic);
12-lead ECG clinically relevant abnormalities that may affect participant safety or interpretation of study results;
Participants with ANY of the following abnormalities in clinical laboratory tests: *AST or ALT level ≥1.5x ULN;
Total bilirubin level ≥1.5x ULN;
TSH> ULN;
Fasting C-peptide <0.8 ng/mL;
Serum calcitonin > ULN;
Amylase > ULN;
Lipase > ULN;
eGFR <60 mL/min/1.73m2 (per MDRD equation);
FPG >270 mg/dL
History of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of Screening;
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing;
History of sensitivity to heparin or heparin induced thrombocytopenia;
Known intolerance to any GLP-1R agonist.

Trial locations and contacts

1 site in 1 country.

United States1 site

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 ORAL DOSES OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled type 2 diabetes mellitus, on metformin and optionally in non-diabetic participants with obesity.

Conditions: Type 2 Diabetes Mellitus
Being tested: PF-07081532, Placebo
Keywords: Type 2 Diabetes Mellitus, Obesity
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.

PF-07081532Drug
Study Drug, once daily for 42 days
PlaceboDrug
Placebo, once daily for 42 days

Study groups in NCT05158244
Study group	Role	What they receive
PF-07081532	Experimental	multiple dosing, once-daily for 42 days Receives: Drug: PF-07081532
Placebo	Placebo comparator	multiple dosing, once-daily for 42 days Receives: Drug: Placebo

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 (All Causalities)
An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE (SAE) was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. A severe AE was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self-care activities of daily living. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period (starting after or on the first dose but before the last dose plus at least 28 days). AEs included all SAEs and non-SAEs.
Measured: Baseline up to at least 28 days after last dose of study intervention (77 days)
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
A treatment related adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, considered related to the study drug (assessed by the investigator [Yes/No]). A serious AE (SAE) was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. A severe AE was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self-care activities of daily living. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period (starting after or on the first dose but before the last dose plus at least 28 days). AEs included all SAEs and non-SAEs.
Measured: Baseline up to at least 28 days after last dose of study intervention (77 days)
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Following laboratory parameters analyzed for laboratory examination: hemoglobin (HGB); hematocrit; erythrocytes; erythrocytes (Ery.) mean corpuscular volume; Ery. mean corpuscular HGB; Ery. mean corpuscular HGB concentration; platelets; leukocytes; lymphocytes; neutrophils; basophils; eosinophils; monocytes; bilirubin; direct bilirubin; indirect bilirubin; aspartate aminotransferase; alanine aminotransferase; gamma glutamyl transferase; alkaline phosphatase; albumin; urea nitrogen; creatinine; urate; cholesterol; high density lipoprotein (HDL) cholesterol; sodium; potassium; chloride; calcium; bicarbonate; thyroxine; free; thyrotropin; creatine kinase; amylase; triacylglycerol lipase; triglycerides; pH; urine glucose; ketones; urine protein; urine hemoglobin; urobilinogen; urine bilirubin; nitrite; leukocyte esterase; urine erythrocytes; urine leukocytes; epithelial cells; casts; and bacteria.
Measured: Baseline up to 7-14 days after last dose of study drug (maximum: 56 days)
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Pre-specified categorical criteria included: supine systolic blood pressure (SBP) less than (<) 90 millimeters of mercury (mmHg), supine SBP increase from baseline greater or equal to (>=) 30 mmHg, supine SBP decrease from baseline >=30 mmHg, supine diastolic blood pressure (DBP) <50 mmHg, supine DBP increase from baseline >=20 mmHg, supine DBP decrease from baseline >=20 mmHg, supine pulse rate <40 beats per minutes (bpm), and supine pulse rate greater than (>) 120 bpm. Supine BP was measured with the participant's arm supported at the level of the heart, and recorded to the nearest mmHg after approximately 5 minutes of rest.
Measured: Baseline up to 14 days after last dose of study intervention (maximum: 56 days)
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
Triplicate 12-lead ECGs were collected using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. Pre-specified categorical criteria included: PR interval greater or equal to 300 msec, PR interval %Chg>=25/50% (%Chg>=25/50% denotes baseline >200 msec and >=25% increase or baseline less than or equal to [<=] 200 msec and >=50% increase), QRS interval >=140 msec, QRS interval increase from baseline >=50%, QT interval corrected using Fridericia's formula (QTcF) >450 msec and <=480 msec, QTcF >480 msec and <=500 msec, QTcF >500 msec, QTcF increase from baseline >30 msec and <=60 msec, and QTcF increase from baseline >60 msec.
Measured: Baseline up to 14 days after last dose of study intervention (maximum: 56 days)

Secondary outcomes (4)

Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42
AUC24 of PF-07081532 were determined by Linear/Log trapezoidal method on Study Day 1 and Study Day 42. On Study Day 1, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 20 mg, 40 mg, and 20 mg, respectively. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42
Cmax of PF-07081532 were observed directly from data from time 0 to 24 hours on Study Day 1 and Study Day 42. On Study Day 1, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 20 mg, 40 mg, and 20 mg, respectively. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Time to Reach Cmax (Tmax) of PF-07081532 on Day 1 and Day 42
Tmax of PF-07081532 were observed directly from data as time of first occurrence on Study Day 1 and Study Day 42. On Study Day 1, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 20 mg, 40 mg, and 20 mg, respectively. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Terminal Half-life (t1/2) of PF-07081532 on Day 42
t1/2 of PF-07081532 was determined by Loge(2)/kel, where 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. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 42

Timeline

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

22 Dec 202115 Jun 2022

First posted15 Dec 2021
Study start22 Dec 2021
Primary completion15 Jun 2022
Study completion15 Jun 2022

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 Type 2 Diabetes MellitusStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05158244
Sponsor's protocol ID: C3991003
Status last verified: Mar 2024
First submitted: 2 Dec 2021
Last updated: 12 Aug 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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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 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 ORAL DOSES OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS
ClinicalTrials.gov ID: NCT05158244
Acronym / sponsor ID: C3991003
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 22 Dec 2021 (actual)
Primary completion: 15 Jun 2022 (actual)
Study completion: 15 Jun 2022 (actual)
First posted: 15 Dec 2021 (actual)
Results: Posted 12 Aug 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: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
PF-07081532	Experimental	Drug: PF-07081532multiple dosing, once-daily for 42 days
Placebo	Placebo comparator	Drug: Placebomultiple dosing, once-daily for 42 days

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Females of non childbearing potential;
Patients with T2DM, inadequately controlled with metformin;
HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c <6.5% (for non-diabetic obese, if enrolled)
Total body weight >50 kg (110 lbs)
BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI >30.5 to ≤45.5 kg/m2 (for non-diabetic obese)

Key exclusion criteria (31 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease;
Medical history of T2DM (for non-diabetic obese participants, if enrolled);
Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
Evidence or history of clinically significant cardiovascular disease;
Any malignancy not considered cured;

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-07081532Study Drug, once daily for 42 days	Drug	PF-07081532
PlaceboPlacebo, once daily for 42 days	Drug	Placebo

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (All Causalities)
Time frame: Baseline up to at least 28 days after last dose of study intervention (77 days)
An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE (SAE) was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. A severe AE was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self-care activities of daily living. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period (starting after or on the first dose but before the last dose plus at least 28 days). AEs included all SAEs and non-SAEs.
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
Time frame: Baseline up to at least 28 days after last dose of study intervention (77 days)
A treatment related adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, considered related to the study drug (assessed by the investigator [Yes/No]). A serious AE (SAE) was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. A severe AE was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self-care activities of daily living. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period (starting after or on the first dose but before the last dose plus at least 28 days). AEs included all SAEs and non-SAEs.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: Baseline up to 7-14 days after last dose of study drug (maximum: 56 days)
Following laboratory parameters analyzed for laboratory examination: hemoglobin (HGB); hematocrit; erythrocytes; erythrocytes (Ery.) mean corpuscular volume; Ery. mean corpuscular HGB; Ery. mean corpuscular HGB concentration; platelets; leukocytes; lymphocytes; neutrophils; basophils; eosinophils; monocytes; bilirubin; direct bilirubin; indirect bilirubin; aspartate aminotransferase; alanine aminotransferase; gamma glutamyl transferase; alkaline phosphatase; albumin; urea nitrogen; creatinine; urate; cholesterol; high density lipoprotein (HDL) cholesterol; sodium; potassium; chloride; calcium; bicarbonate; thyroxine; free; thyrotropin; creatine kinase; amylase; triacylglycerol lipase; triglycerides; pH; urine glucose; ketones; urine protein; urine hemoglobin; urobilinogen; urine bilirubin; nitrite; leukocyte esterase; urine erythrocytes; urine leukocytes; epithelial cells; casts; and bacteria.
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Time frame: Baseline up to 14 days after last dose of study intervention (maximum: 56 days)
Pre-specified categorical criteria included: supine systolic blood pressure (SBP) less than (<) 90 millimeters of mercury (mmHg), supine SBP increase from baseline greater or equal to (>=) 30 mmHg, supine SBP decrease from baseline >=30 mmHg, supine diastolic blood pressure (DBP) <50 mmHg, supine DBP increase from baseline >=20 mmHg, supine DBP decrease from baseline >=20 mmHg, supine pulse rate <40 beats per minutes (bpm), and supine pulse rate greater than (>) 120 bpm. Supine BP was measured with the participant's arm supported at the level of the heart, and recorded to the nearest mmHg after approximately 5 minutes of rest.
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
Time frame: Baseline up to 14 days after last dose of study intervention (maximum: 56 days)
Triplicate 12-lead ECGs were collected using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. Pre-specified categorical criteria included: PR interval greater or equal to 300 msec, PR interval %Chg>=25/50% (%Chg>=25/50% denotes baseline >200 msec and >=25% increase or baseline less than or equal to [<=] 200 msec and >=50% increase), QRS interval >=140 msec, QRS interval increase from baseline >=50%, QT interval corrected using Fridericia's formula (QTcF) >450 msec and <=480 msec, QTcF >480 msec and <=500 msec, QTcF >500 msec, QTcF increase from baseline >30 msec and <=60 msec, and QTcF increase from baseline >60 msec.

4 secondary outcomes

Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Time to Reach Cmax (Tmax) of PF-07081532 on Day 1 and Day 42
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Terminal Half-life (t1/2) of PF-07081532 on Day 42
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 42

Results and safety

Results posted to the registry on 12 Aug 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 (Type 2 Diabetes Mellitus [T2DM])	6	5
PF-07081532 20-60 mg (T2DM)	8	8
PF-07081532 40-80 mg (T2DM)	9	8
Placebo (Obesity)	2	2
PF-07081532 20-60 mg (Obesity)	9	9

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (All Causalities)

Time frame: Baseline up to at least 28 days after last dose of study intervention (77 days). Count of participants. Unit: Participants

Measure	Placebo (Type 2 Diabetes Mellitus [T2DM]) n = 6	PF-07081532 20-60 mg (T2DM) n = 8	PF-07081532 40-80 mg (T2DM) n = 9	PF-07081532 20-60 mg (Obesity) n = 9
Participants with AEs	5	7	6	7
Participants with SAEs	0	0	0	0
Participants with severe AEs	0	0	0	0
Participants with AEs leading to permanent discontinuation from study	0	0	0	0

Population analysed: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (Treatment Related)

Time frame: Baseline up to at least 28 days after last dose of study intervention (77 days). Count of participants. Unit: Participants

Measure	Placebo (Type 2 Diabetes Mellitus [T2DM]) n = 6	PF-07081532 20-60 mg (T2DM) n = 8	PF-07081532 40-80 mg (T2DM) n = 9	PF-07081532 20-60 mg (Obesity) n = 9
Participants with AEs	5	6	6	7
Participants with SAEs	0	0	0	0
Participants with severe AEs	0	0	0	0
Participants with AEs leading to permanent discontinuation from study	0	0	0	0

Population analysed: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Primary outcome: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Time frame: Baseline up to 7-14 days after last dose of study drug (maximum: 56 days). Count of participants. Unit: Participants

Measure	Placebo (Type 2 Diabetes Mellitus [T2DM]) n = 5	PF-07081532 20-60 mg (T2DM) n = 8	PF-07081532 40-80 mg (T2DM) n = 9	Placebo (Obesity) n = 2	PF-07081532 20-60 mg (Obesity) n = 9
HGB (grams per deciliter [g/dL]) <0.8 x lower of limit of normal (LLN)	1	0	0	0	0
Hematocrit (%) <0.8 x LLN	0	0	0	0	0
Erythrocytes (10^6/mm^3) <0.8 x LLN	0	0	0	0	0
Ery. Mean Corpuscular Volume (10^-15 liters [L]) <0.9 x LLN	0	0	0	0	0
Ery. Mean Corpuscular Volume (10^-15 L) >1.1 x upper limit of normal (ULN)	0	0	0	0	0
Ery. Mean Corpuscular HGB (picograms per cell [pg/cell]) <0.9 x LLN	0	0	0	0	0
Ery. Mean Corpuscular HGB (pg/cell) >1.1 x ULN	0	0	0	0	0
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9 x LLN	0	0	0	0	0

Population analysed: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention and had at least 1 observation of the given laboratory test while on study treatment or during follow up. Here, "number analyzed" signifies number of participants evaluable for each category.

Primary outcome: Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data

Time frame: Baseline up to 14 days after last dose of study intervention (maximum: 56 days). Count of participants. Unit: Participants

Measure	Placebo (Type 2 Diabetes Mellitus [T2DM]) n = 6	PF-07081532 20-60 mg (T2DM) n = 8	PF-07081532 40-80 mg (T2DM) n = 9	Placebo (Obesity) n = 2	PF-07081532 20-60 mg (Obesity) n = 9
Supine SBP <90 mmHg	0	1	0	0	0
Supine SBP increase from baseline >=30 mmHg	0	0	1	0	0
Supine SBP decrease from baseline >=30 mmHg	1	4	2	1	2
Supine DBP <50 mmHg	0	0	0	0	0
Supine DBP increase from baseline >=20 mmHg	0	0	0	0	0
Supine DBP decrease from baseline >=20 mmHg	0	0	0	0	0
Pulse rate <40 bpm	0	0	0	0	0
Pulse rate >120 bpm	0	0	0	0	0

Population analysed: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 77 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Type 2 Diabetes Mellitus [T2DM])	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
PF-07081532 20-60 mg (T2DM)	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
PF-07081532 40-80 mg (T2DM)	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Placebo (Obesity)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
PF-07081532 20-60 mg (Obesity)	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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

1 site 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 in people with Type 2 Diabetes Mellitus, run by Pfizer at 1 site 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 5 inclusion and 31 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 12 Aug 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 Adverse Events (All Causalities) (time frame: Baseline up to at least 28 days after last dose of study intervention (77 days)). The study lists 5 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 NCT05158244, 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 12 Aug 2024.