A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)
Purpose
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).
Conditions
- Overweight
- Obesity
- Overweight and/or Obesity
- Overweight or Obesity
- Overnutrition
- Nutrition Disorders
- Nutritional and Metabolic Diseases
- Body Weight
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 |
Participants receive subcutaneous injections of PF-08653945 or placebo. |
|
|
Experimental Cohort 2 |
Participants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo. |
|
|
Experimental Cohort 3 |
Participants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo. |
|
Recruiting Locations
Walnut Creek, California 94598
Butte, Montana 59701
Las Vegas, Nevada 89119
Charlotte, North Carolina 28210
Monroe, North Carolina 28112
Statesville, North Carolina 28625
Hendersonville, Tennessee 37075
Houston, Texas 77040
Tomball, Texas 77375
More Details
- Status
- Recruiting
- Sponsor
- Pfizer