A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Overweight and/or Obesity; Nutrition Disorders; Overweight or Obesity; Overweight; Overnutrition; Obesity; Body Weight; Nutritional and Metabolic Diseases

Treatments: Drug: PF-08653944; Drug: PF-08653945; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07575932

SOLIS-1 (Other Identifier)

C6511002

Details and patient eligibility

About

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).

Enrollment: 872 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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872 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Participants receive subcutaneous injections of PF-08653945 or placebo.

Treatment:

Drug: Placebo

Drug: PF-08653945

Cohort 2

Experimental group

Description:

Participants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo.

Treatment:

Drug: Placebo

Drug: PF-08653945

Drug: PF-08653944

Cohort 3

Experimental group

Description:

Participants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo.

Treatment:

Drug: Placebo

Drug: PF-08653945

Drug: PF-08653944