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Type 2 Diabetes Mellitus (T2DM)Phase 1NCT06279234

A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus

A Phase 1 study testing Rosuvastatin, Midazolam and Omeprazole in people with Type 2 Diabetes Mellitus (T2DM) and Obesity, 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

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes mellitus (T2DM) on metformin (Part A) and optionally in non-diabetic participants with… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM), Obesity
What is being tested?
Rosuvastatin, Midazolam and Omeprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
2 sitesUnited States
Study dates
20 Feb 2024to 11 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • Female participants of non-childbearing potential and males between the ages of 18 and 70 years, inclusive, at the time of signing the ICD.
  • Part A only: Diagnosis of Diabetes - Participants enrolling with T2DM must have a clinical history of T2DM and be taking metformin monotherapy as their only anti-hyperglycemic treatment. Metformin dose must be at least 500 mg per day and must be stable, defined as no change in the treatment, including dose, for at least 2 months prior to the screening visit.
  • Part C only: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • HbA1c
  • Part A only: For participants enrolling with T2DM: HbA1c ≥7.0% and ≤10.5% at screening (confirmed by a single repeat, if necessary).
  • Part B and C only: For participants enrolling as non-diabetic with obesity (Part B), or healthy (Part C): HbA1c <6.5% at screening.
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  • BMI
  • All participants must have a total body weight >50 kg (110 lbs).
  • Parts A and B only: Stable body weight, defined as <5 kg change (per participant report) for 90 days prior to screening
  • Part A only: For participants enrolling with T2DM: BMI ≥24.5 to ≤45.5 kg/m2.
  • Part B only: For participants enrolling as non-diabetic with obesity: BMI >30.5 to ≤45.5 kg/m2
  • Part C only: For participants enrolling as healthy: BMI 20-30.5 kg/m2
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Parts A and B only: Participants with T2DM (Part A) or obesity (Part B) are allowed. Participants who have chronic conditions other than T2DM and obesity (eg, hypercholesterolemia or hypertension) but are controlled by either diet or stable doses of 2 or fewer medications may be included (eg, a participant with hypercholesterolemia on appropriate treatment is eligible).
  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency).
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
  • Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.
  • Parts B and C only: Participants enrolling as non-diabetic with obesity (Part B) or healthy (Part C) may not have medical history of T2DM.
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  • Evidence or history of clinically significant cardiovascular disease. In particular, history of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening.
  • Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin); a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years.
  • Acute pancreatitis or history of chronic pancreatitis.
  • Acute gallbladder disease.
  • Parts A and B only: A response of 'yes' to question 4 or 5 or on any behavioral question on the C-SSRS at Screening or Day -1 in the study. In addition, participants deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.
  • Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgement.
  • Any medical or psychiatric condition including recent (within the past year) history of: suicidal ideation/behavior, major depressive disorder, schizophrenia, bipolar disorder; or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
  • Use of prescription or nonprescription drugs and dietary and herbal supplements that are BCRP, MDR1/P-gp, or OATP inhibitors is prohibited within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention; use of moderate or strong inhibitors or inducers of CYP3A, UGT1A1, or UGT1A3 is prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
  • Part A and B: Use of certain concomitant medication that are unlikely to interfere with the study results may be allowed. However, use of prescription or nonprescription drugs and dietary and herbal supplements that are sensitive CYP1A2, CYP2C19, CYP3A, BCRP, MDR1/P-gp, OATP1B3, or UGT1A1 substrates is prohibited post Day -1.
  • Part C: Use of moderate or strong inhibitors or inducers of CYP2C19 are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention. Use of all other prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
  • Use of any prohibited prior/concomitant medication(s) or participant unwilling or unable to use a required concomitant medication(s).
  • Previous administration of an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • Known prior participation (ie, randomized and received at least 1 dose of study intervention) in a trial involving PF-06954522. Note that a given individual may only participate in a single cohort of this study.
  • A positive urine drug screen at screening or admission. Participants who have been medically prescribed benzodiazepines and report the use of these drugs to the investigator at the screening visit may be allowed to participate if approved by the sponsor.
  • Parts A and B only: Screening supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Part C only: Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 ms, complete left bundle branch block, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree atrioventricular block, or serious bradyarrhythmias or tachyarrhythmias).
  • If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test if deemed necessary:
  • AST or ALT level ≥1.5 × ULN;
  • Total bilirubin level ≥1.5 × ULN; participants with an elevated total bilirubin consistent with Gilbert's Disease will have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ULN;
  • TSH > ULN;
  • Fasting C-peptide <0.8 ng/mL;
  • Serum calcitonin > ULN;
  • Amylase > ULN;
  • Lipase > ULN.
  • Fasting blood glucose
  • Part A only: >270 mg/dL at screening or admission, confirmed by a single repeat test if deemed necessary.
  • Parts B and C only: >126 mg/dL at screening or admission, confirmed by a single repeat test if deemed necessary.
  • Renal impairment as defined by an eGFR <75 mL/min/1.73m2. Confirmation of screening eGFR by a single repeat test is permitted, if deemed necessary.
  • Based upon participant age at screening, eGFR is calculated using the recommended CKD-EPI equations in Section 10.7.2 to determine eligibility (Screat-based formula).
  • History of alcohol abuse or binge drinking and/or any illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces ([240 mL] beer, 1 ounce [30 mL] of 40% spirit or 3 ounces [90 mL] of wine).
  • Prior use of a GLP-1R agonist within 6 months prior to screening or known intolerance to any GLP-1R agonist.
  • Body weight exceeds the maximum capacity of the site's body weight scale, preventing accurate assessment of body weight.
  • Part C only: History of hypersensitivity, intolerance, or allergic reaction associated with prior exposure to rosuvastatin, midazolam, or omeprazole.
  • Part C only: Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
  • Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

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-06954522 in Adult Participants With Type 2 Diabetes Mellitus

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes mellitus (T2DM) on metformin (Part A) and optionally in non-diabetic participants with obesity (Part B).

Being tested
Placebo, Rosuvastatin, Midazolam, Omeprazole, PF-06954522
Keywords
T2DM, Obesity, PF-06954522, Rosuvastatin, Midazolam, Omeprazole, DDI, C4001002
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.

Study groups in NCT06279234
Study groupRoleWhat they receive
Part AExperimentalMultiple doses of PF 06954522 or placebo daily for up to 8 weeks in adult participants with T2DM in up to 7 cohorts.
Receives: Drug: Placebo; Drug: PF-06954522
Part B (Optional)ExperimentalMultiple doses of PF 06954522 or placebo daily for up to 8 weeks in non-diabetic adult participants with obesity in up to 3 cohorts.
Receives: Drug: Placebo; Drug: PF-06954522
Part C (Optional)ExperimentalAn 8-period multiple-dose assessment of the effect of PF-06954522 on rosuvastatin, midazolam, and omeprazole PK in healthy adult participants for up to 14 weeks in healthy adult participants.
Receives: Drug: Rosuvastatin; Drug: Midazolam; Drug: Omeprazole; Drug: PF-06954522

What is being measured

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

  1. Number of Participants Reporting Adverse Events

    Measured: Baseline through Week 14

  2. Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities

    Measured: Baseline through Week 14

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: Baseline through Week 14

  4. Number of Participants With Clinically Significant Change From Baseline in 12-Lead ECGs

    Measured: Baseline through Week 14

  5. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Measured: Baseline through Week 14

Secondary outcomes (7)

  1. Maximum Observed Plasma Concentration (Cmax)

    Measured: Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24, 30. Part A & B: Days -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28

  2. Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

    Measured: Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24, 30. Part A & B: Days -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57, 58. Part C: Period 3 Day 3 & Period 5 Day 28

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24 & 30. Part A & B: Day -1, 1 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28

  4. Plasma Decay Half-Life (t1/2)

    Measured: Part A: Day -1, 1,14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24 & 30. Part A & B: Day -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28

  5. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

    Measured: Part A: Day 28. Part A & B: Day 56

  6. Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)

    Measured: Part A: Day 28. Part A & B: Day 56

  7. Renal Clearance (CLr)

    Measured: Part A: Day 28. Part A & B: Day 56

Timeline

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

  1. First posted28 Feb 2024
  2. Study start20 Feb 2024
  3. Primary completion11 Apr 2025
  4. Study completion11 Apr 2025

Resources

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
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279234
Sponsor's protocol ID
C4001002
Other IDs
NCT06279234
Status last verified
Jun 2025
First submitted
19 Feb 2024
Last updated
3 Jun 2025
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rosuvastatin, Midazolam and Omeprazole in people with Type 2 Diabetes Mellitus (T2DM) and Obesity, 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 13 inclusion and 43 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 3 Jun 2025. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Reporting Adverse Events (time frame: Baseline through Week 14). 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 NCT06279234.

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 3 Jun 2025.

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