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
Chandler, Arizona 85225
Sun City West, Arizona 85375
Tucson, Arizona 85711
Canoga Park, California 91304
Fountain Valley, California 92708
Garden Grove, California 92840
Lomita, California 90717
Long Beach, California 90815
Los Alamitos, California 90720
Modesto, California 95355
San Diego, California 92108
Tustin, California 92780
Walnut Creek, California 94598
Hialeah, Florida 33012
Jacksonville, Florida 32205
Miami, Florida 33165
Orlando, Florida 32803
Atlanta, Georgia 30318
Stockbridge, Georgia 30281
Morton, Illinois 61550
Naperville, Illinois 60540
Lenexa, Kansas 66219
Mandeville, Louisiana 70471
Prairieville, Louisiana 70769
Lutherville, Maryland 21093
Springfield, Missouri 65807
Butte, Montana 59701
Las Vegas, Nevada 89109
Las Vegas, Nevada 89119
Las Vegas, Nevada 89128
Hamilton, New Jersey 08690
Charlotte, North Carolina 28210
Monroe, North Carolina 28112
Statesville, North Carolina 28625
Wilmington, North Carolina 28401
Edmond, Oklahoma 73013
Pittsburgh, Pennsylvania 15236
Uniontown, Pennsylvania 15401
Uniontown, Pennsylvania 15401
Myrtle Beach, South Carolina 29572
Hendersonville, Tennessee 37075
Euless, Texas 76040
Houston, Texas 77040
Kingwood, Texas 77339
Plano, Texas 75093
Prosper, Texas 75078
San Antonio, Texas 78217
San Antonio, Texas 78258
Shavano Park, Texas 78231
Tomball, Texas 77375
Salt Lake City, Utah 84102
Salt Lake City, Utah 84107
Arlington, Virginia 22206
Manassas, Virginia 20110
Vienna, Virginia 22182
More Details
- Status
- Recruiting
- Sponsor
- Pfizer