Recruiting

Phase 2

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

Sponsor:

Pfizer

Code:

NCT07575932

Conditions

Overweight

Obesity

Overweight and/or Obesity

Overweight or Obesity

Overnutrition

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08653945

PF-08653944

Placebo

Study Details

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).

Conditions

Overweight

Obesity

Overweight and/or Obesity

Overweight or Obesity

Overnutrition

Study ID

NCT07575932

Start date

May 11, 2026

Status verified date

Aug, 2026

Completion date

Jan 5, 2028

Anticipated

Primary completion date

Aug 4, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

872 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

PF-08653945

Subcutaneous Injection

PF-08653944

Subcutaneous Injection

Placebo

Subcutaneous Injection

Primary outcome measure

Percent change from baseline in body weight [ Time Frame: Baseline (Week 0) to Week 48 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Arizona Clinical Trials-Chandler

Recruiting

Chandler, Arizona, United States, 85225

Clinical Research Institute of Arizona

Recruiting

Sun City West, Arizona, United States, 85375

Arizona Clinical Trials (ACT) - Tucson

Recruiting

Tucson, Arizona, United States, 85711

San Fernando Valley Health Institute

Recruiting

Canoga Park, California, United States, 91304

Ark Clinical Research

Recruiting

Fountain Valley, California, United States, 92708

Paragon Rx Clinical

Recruiting

Garden Grove, California, United States, 92840

Torrance Clinical Research Institute, Inc.

Recruiting

Lomita, California, United States, 90717

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Collaborative Neuroscience Research, LLC

Recruiting

Los Alamitos, California, United States, 90720

Paradigm Clinical Research-Modesto

Recruiting

Modesto, California, United States, 95355

Paradigm Clinical Research Centers, LLC

Recruiting

San Diego, California, United States, 92108

University Clinical Investigators, Incorporated

Recruiting

Tustin, California, United States, 92780

Diablo Clinical Research, LLC dba Flourish Research

Recruiting

Walnut Creek, California, United States, 94598

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012

Westside Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32205

New Horizon Research Center

Recruiting

Miami, Florida, United States, 33165

Charter Research

Recruiting

Orlando, Florida, United States, 32803

Atlanta Diabetes Associates

Recruiting

Atlanta, Georgia, United States, 30318

Clinical Research Atlanta

Recruiting

Stockbridge, Georgia, United States, 30281

Koch Family Medicine Clinical Research/Elite Research Network

Recruiting

Morton, Illinois, United States, 61550

Bioluminux Clinical Research Illinois

Recruiting

Naperville, Illinois, United States, 60540

Johnson County Clinical Trials

Recruiting

Lenexa, Kansas, United States, 66219

DelRicht Research

Recruiting

Mandeville, Louisiana, United States, 70471

DelRicht Research

Recruiting

Prairieville, Louisiana, United States, 70769

Patient First Clinical Trials (PFCTRIALS)

Recruiting

Lutherville, Maryland, United States, 21093

DelRicht Research

Recruiting

Springfield, Missouri, United States, 65807

Mercury Street Medical Group, PLLC

Recruiting

Butte, Montana, United States, 59701

Alliance Clinical Research Las Vegas (Excel Clinical Research)

Recruiting

Las Vegas, Nevada, United States, 89109

AB Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89119

Palm Research Center

Recruiting

Las Vegas, Nevada, United States, 89128

Bioluminux Clinical Research

Recruiting

Hamilton, New Jersey, United States, 08690

DelRicht Research

Recruiting

Charlotte, North Carolina, United States, 28211

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Piedmont Healthcare

Recruiting

Statesville, North Carolina, United States, 28625

Accellacare - Wilmington

Recruiting

Wilmington, North Carolina, United States, 28401

Tekton Research, LLC.

Recruiting

Edmond, Oklahoma, United States, 73013

Preferred Primary Care Physicians

Recruiting

Pittsburgh, Pennsylvania, United States, 15236

Preferred Primary Care Physicians, Inc.

Recruiting

Uniontown, Pennsylvania, United States, 15401

Preferred Primary Care Physicians

Recruiting

Uniontown, Pennsylvania, United States, 15401

TMA Headlands LLC (d/b/a Trial Management Associates)

Recruiting

Myrtle Beach, South Carolina, United States, 29572

DelRicht Research

Recruiting

Hendersonville, Tennessee, United States, 37075

Cedar Health Research - Euless

Recruiting

Euless, Texas, United States, 76040

JCCT-JUNO NW Houston

Recruiting

Houston, Texas, United States, 77040

Activian Clinical Research

Recruiting

Kingwood, Texas, United States, 77339

3A Research

Recruiting

Plano, Texas, United States, 75093

DelRicht Research @ Zomnir Family Medicine

Recruiting

Prosper, Texas, United States, 75078

Worldwide Clinical Trials

Recruiting

San Antonio, Texas, United States, 78217

Tekton Research, LLC.

Recruiting

San Antonio, Texas, United States, 78258

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

DM Clinical Research

Recruiting

Tomball, Texas, United States, 77375

Alpine Medical Group

Recruiting

Salt Lake City, Utah, United States, 84102

Wasatch Clinical Research, LLC

Recruiting

Salt Lake City, Utah, United States, 84107

Washington Center for Weight Management and Research

Recruiting

Arlington, Virginia, United States, 22206

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

DelRicht Research

Recruiting

Vienna, Virginia, United States, 22182

Viable Clinical Research Corporation

Recruiting

Bridgewater, Nova Scotia, Canada, B4V 3N2

Aggarwal and Associates Limited

Recruiting

Brampton, Ontario, Canada, L6T 0G1

Centricity Research Etobicoke Endocrinology

Recruiting

Etobicoke, Ontario, Canada, M9R 4E1

Milestone Research Inc.

Recruiting

London, Ontario, Canada, N5W 6A2

Bluewater Clinical Research Group Inc.

Recruiting

Sarnia, Ontario, Canada, N7T 4X3

Dr. Anil K. Gupta Medicine Professional Corporation

Recruiting

Toronto, Ontario, Canada, M9V 4B4

Centricity Research Toronto Manna Multispecialty

Recruiting

Toronto, Ontario, Canada, M9W 4L6

Ecogene-21

Recruiting

Chicoutimi, Quebec, Canada, G7H 7K9

Centricity Research Mirabel Multispecialty

Recruiting

Mirabel, Quebec, Canada, J7J 2K8

Recherche GCP Research

Recruiting

Montreal, Quebec, Canada, H1Y 3H5

More Information

Sponsor

Pfizer

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

Overnutrition
Nutrition Disorders
Nutritional and Metabolic Diseases
Body Weight
Obesity
Overweight
GLP-1RA
Amylin
DACRA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-17.