HealthyPhase 1NCT07519135
A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function
A Phase 1 study testing PF-08653944 in people with Healthy, run by Pfizer at 3 sites in United States.
Trial summary
This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose. The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-08653944
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2026to 9 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 to 75 years of age, male or female.
- BMI ≥21 kg/m² and body weight >50 kg at screening.
- Group 1 (without hepatic impairment):
- No known or suspected hepatic impairment.
- Normal liver function tests (ALT, AST, bilirubin, albumin, PT within normal limits, with protocol-specified exceptions such as Gilbert's syndrome).
- Groups 2-4 (with hepatic impairment):
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- Stable hepatic impairment classified as Child-Pugh Class A (mild), B (moderate), or C (severe).
- No clinically significant worsening of hepatic status within 28 days prior to screening.
- Women of childbearing potential must not be pregnant or breastfeeding and must agree to use highly effective contraception.
Who cannot join
- Clinically significant medical or psychiatric conditions, including recent or active suicidal ideation or behavior.
- Use of GLP-1 receptor agonists within 90 days (or 5 half-lives) prior to dosing.
- Participation in another investigational study or receipt of an investigational product within 30 days (or 5 half-lives) prior to dosing.
- For hepatic-impairment groups only:
- Hepatic carcinoma, hepatorenal syndrome, or limited life expectancy.
- Clinically active Grade 3 or 4 hepatic encephalopathy.
- Severe uncontrolled ascites, recent gastrointestinal bleeding, or history of solid organ transplant.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Floridian Clinical Research
Miami Lakes, Florida, 33016
- Recruiting
Orlando Clinical Research Center
Orlando, Florida, 32809
- Recruiting
Genesis Clinical Research
Tampa, Florida, 33603
About this study
Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-08653944 IN ADULTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIRMENT
This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose.
The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. By comparing these groups, researchers want to understand whether liver function changes how the medicine behaves in the body.
Read more
People who join the study will receive one injection of the study medicine. They will stay at the study clinic for a short time and return for follow-up visits so doctors can do blood tests, physical exams, and safety checks.
This study is not expected to provide direct medical benefit to participants. The information collected will help researchers develop future treatments and understand how this medicine may be used safely in people with liver disease.
- Conditions
- Healthy
- Being tested
- PF-08653944
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08653944Drug
Also called MET097
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection. Receives: Drug: PF-08653944 |
| Group 2 | Experimental | Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection. Receives: Drug: PF-08653944 |
| Group 3 | Experimental | Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection. Receives: Drug: PF-08653944 |
| Group 4 | Experimental | Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection. Receives: Drug: PF-08653944 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944
Measured: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
PK: Area under the plasma concentration (AUC) of PF-08653944
Measured: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Secondary outcomes (1)
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: First dose through study completion, approximately 11 Weeks after last dose of study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start15 Apr 2026
- Primary completion9 Jul 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519135
- Sponsor's protocol ID
- C6491009
- Other IDs
- MET097-25-105
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 23 Apr 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-08653944 IN ADULTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIRMENT
- ClinicalTrials.gov ID
- NCT07519135
- Acronym / sponsor ID
- C6491009
- Conditions
- Healthy
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose.
The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. By comparing these groups, researchers want to understand whether liver function changes how the medicine behaves in the body.
People who join the study will receive one injection of the study medicine. They will stay at the study clinic for a short time and return for follow-up visits so doctors can do blood tests, physical exams, and safety checks.
This study is not expected to provide direct medical benefit to participants. The information collected will help researchers develop future treatments and understand how this medicine may be used safely in people with liver disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: PF-08653944Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection. |
| Group 2 | Experimental | Drug: PF-08653944Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection. |
| Group 3 | Experimental | Drug: PF-08653944Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection. |
| Group 4 | Experimental | Drug: PF-08653944Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults 18 to 75 years of age, male or female.
- BMI ≥21 kg/m² and body weight >50 kg at screening.
- Group 1 (without hepatic impairment):
- Groups 2-4 (with hepatic impairment):
- Women of childbearing potential must not be pregnant or breastfeeding and must agree to use highly effective contraception.
Key exclusion criteria (7 listed)
- Clinically significant medical or psychiatric conditions, including recent or active suicidal ideation or behavior.
- Use of GLP-1 receptor agonists within 90 days (or 5 half-lives) prior to dosing.
- Participation in another investigational study or receipt of an investigational product within 30 days (or 5 half-lives) prior to dosing.
- For hepatic-impairment groups only:
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-08653944Also: MET097Solution for injection | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944
Time frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
PK: Area under the plasma concentration (AUC) of PF-08653944
Time frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
1 secondary outcome
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: First dose through study completion, approximately 11 Weeks after last dose of study intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- 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.
Pfizer CT.gov Call Center study director
Pfizer
3 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-08653944 in people with Healthy, run by Pfizer at 3 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944 (time frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.