Body Weight, Nutritional and Metabolic Diseases, Nutrition Disorders, Obesity, Overnutrition, Overweight, Overweight and/or Obesity, Overweight or Obesity
Conditions
Keywords
Overnutrition, Nutrition Disorders, Nutritional and Metabolic Diseases, Body Weight, Obesity, Overweight, GLP-1RA, Amylin, DACRA
Brief summary
This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).
Interventions
DRUGPF-08653945
Subcutaneous Injection
DRUGPF-08653944
Subcutaneous Injection
DRUGPlacebo
Subcutaneous Injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants for this study include: * adults aged 18 years or older with * obesity (BMI of 30.0 kg/m2 to 50.0 kg/m2) or with * overweight (BMI of 27.0 kg/m2 to \<30.0 kg/m2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea), at the screening visit.
Exclusion criteria
Participants who are not eligible include those with diabetes mellitus, a body weight change of \>5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight | Baseline (Week 0) to Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight | Baseline (Week 0) to Week 60 |
| Change from baseline in body weight | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥5% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥10% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥15% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥20% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥25% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to Week 70 |
Countries
Canada, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed