A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
The purpose of this study is to learn about:
* How PF-08653944 is changed and removed from the body after taken * Safety of PF-08653944 * The extent to which side effects can be tolerated after taking PF- 08653944 for the possible treatment of heart failure
This study is seeking participants who:
* Are healthy Chinese adults who are aged 18 years and older * Have body mass index of 24 - 45 kilograms/meter2 * Have a total body weight of equal to or more than 50 kilograms (110 pounds) * Do not have prior significant medical conditions, history of drug or alcohol abuse
All participants in this study will receive a single dose of PF-08653944 at the study clinic.
The experiences of the participants receiving the study medicine will be looked at. This will help to see if the study medicine is safe.
Participants will take part in this study for around 16 weeks. During this time, they will have 6 study visits at the study clinic.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 24-45 kg/m2; and a total body weight >50 kg (110 lb).
Chinese participants are defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PF-08653944
DrugSolution for injection
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Treatment 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
Time frame
Up to 85 days2
PK: Maximum Observed Concentration (Cmax) of PF-08653944
Time frame
Up to 85 daysSecondary outcomes
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame
Up to 85 days Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: