Healthy, Obesity, Overweight
Conditions
Keywords
obesity, overweight, biological availability, pharmacokinetics
Brief summary
This study is being done to learn how the study medicine affects the body. It will also assess how safe it is for people who take it. The researchers will use blood tests to measure how much medicine is in the blood. This study is seeking adults who are: * obese or overweight with weight-related health conditions, and * Meet health and other checks assessed by the study doctor. The study team will give a single dose of the study treatment at the clinic to the participants. At each study visit, blood samples will be collected and vital signs will be checked. The study team will also ask about any reactions or health changes. Vital signs are basic measurements that show how well the body is working. They help the study team quickly understand a participant's overall health. These usually include body temperature, heart rate, breathing rate, and blood pressure. The study involves multiple clinic visits at a study site over the length of the study. The information collected will help researchers understand how the study medicine works and whether it is safe.
Interventions
DRUGPF-08653945
Subcutaneous Injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants 18 years of age or older at Screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. * BMI of 27-45 kg/m2; and a total body weight \>50 kg (110 lb). * For Japanese participants (Optional Cohort 2) only: BMI of 22-45 kg/m2 and a total body weight \>50 kg (110 lb). NOTE: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.
Exclusion criteria
* Pregnant or breastfeeding women, or those planning pregnancy during the study. * Clinically significant medical conditions including hematologic, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis, gallbladder disease, clinically relevant gastric emptying disorders), cardiovascular, hepatic, psychiatric, neurologic, or severe allergic diseases. * Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC. * Active or recent suicidal ideation in the past year, suicidal behavior within the past 5 years, or any psychiatric condition that increases risk in the investigator's judgment. * Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect GI motility. * Acute gastrointestinal symptoms at screening or Day -1. * Known hypersensitivity to PF-08653945, amylin or calcitonin agonists, or any excipients. * Prior participation in any study involving PF-08653945 (formerly MET233) with at least one dose received.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Curve (AUC) of PF-08653945 | Up to 57 days post-dose | AUC is a measure of the plasma concentration of the study drug over time. It is used to characterize absorption of the drug. |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08653945 | Up to 57 days post-dose | Cmax refers to the maximum observed serum concentration of the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 57 days | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Countries
Belgium
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed