PHASE 1, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PARALLEL GROUP, PK COMPARABILITY STUDY BETWEEN DIFFERENT DELIVERY SYSTEMS OF BEROBENATIDE IN ADULTS WITH OVERWEIGHT OR OBESITY
Pfizer
Summary
This is a single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity. Overweight or obesity means having more body fat than what is healthy. The study involves multiple clinic visits at a study site over the length of the study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria: * Participants 18 years of age or older * BMI of 27-45 kg/m2; and a total body weight \>50 kg (110 lb) Key Exclusion Criteria: * Pregnant or breastfeeding women, or those planning pregnancy during the study * History of other chronic disorders * Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC * Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect gastrointestinal (GI) motility * Acute GI symptoms at screening, Day -1, or prior t…
Interventions
- DrugBerobenatide
Solution for Injection
Location
- Anaheim Clinical Trials, LLCAnaheim, California