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OverweightPhase 2SOLIS-1NCT07575932

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity

A Phase 2 study testing PF-08653945 and PF-08653944 in people with Overweight and Obesity, run by Pfizer at 63 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity, Overweight and/or Obesity
What is being tested?
PF-08653945 and PF-08653944
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
940 participants
Where
63 sitesin 2 countries
Study dates
11 May 2026to 5 Jan 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

63 sites in 2 countries.

63 sites in 2 countries

United States53 sites

  • Washington Center for Weight Management and Research

    Arlington, Virginia, 22206

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • San Fernando Valley Health Institute

    Canoga Park, California, 91304

  • DelRicht Research

    Charlotte, North Carolina, 28211

  • Cedar Health Research - Euless

    Euless, Texas, 76040

  • Ark Clinical Research

    Fountain Valley, California, 92708

  • Paragon Rx Clinical

    Garden Grove, California, 92840

  • Bioluminux Clinical Research

    Hamilton, New Jersey, 08690

  • DelRicht Research

    Hendersonville, Tennessee, 37075

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • JCCT-JUNO NW Houston

    Houston, Texas, 77040

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Activian Clinical Research

    Kingwood, Texas, 77339

  • Alliance Clinical Research Las Vegas (Excel Clinical Research)

    Las Vegas, Nevada, 89109

  • AB Clinical Trials

    Las Vegas, Nevada, 89119

  • Palm Research Center

    Las Vegas, Nevada, 89128

  • Johnson County Clinical Trials

    Lenexa, Kansas, 66219

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • Ark Clinical Research

    Long Beach, California, 90815

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720

  • Patient First Clinical Trials (PFCTRIALS)

    Lutherville, Maryland, 21093

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • DelRicht Research

    Mandeville, Louisiana, 70471

  • New Horizon Research Center

    Miami, Florida, 33165

  • Paradigm Clinical Research-Modesto

    Modesto, California, 95355

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Koch Family Medicine Clinical Research/Elite Research Network

    Morton, Illinois, 61550

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

    Myrtle Beach, South Carolina, 29572

  • Bioluminux Clinical Research Illinois

    Naperville, Illinois, 60540

  • Tekton Research, LLC.

    Oklahoma City, Oklahoma, 73134

  • Charter Research

    Orlando, Florida, 32803

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • 3A Research

    Plano, Texas, 75093

  • DelRicht Research

    Prairieville, Louisiana, 70769

  • DelRicht Research @ Zomnir Family Medicine

    Prosper, Texas, 75078

  • Alpine Medical Group

    Salt Lake City, Utah, 84102

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Worldwide Clinical Trials

    San Antonio, Texas, 78217

  • Tekton Research, LLC.

    San Antonio, Texas, 78258

  • Paradigm Clinical Research Centers, LLC

    San Diego, California, 92108

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • DelRicht Research

    Springfield, Missouri, 65807

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Clinical Research Institute of Arizona

    Sun City West, Arizona, 85375

  • DM Clinical Research

    Tomball, Texas, 77375

  • University Clinical Investigators, Incorporated

    Tustin, California, 92780

  • Preferred Primary Care Physicians, Inc.

    Uniontown, Pennsylvania, 15401

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • DelRicht Research

    Vienna, Virginia, 22182

  • Diablo Clinical Research, LLC dba Flourish Research

    Walnut Creek, California, 94598

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

Canada10 sites

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1

  • Viable Clinical Research Corporation

    Bridgewater, Nova Scotia, B4V 3N2

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Milestone Research Inc.

    London, Ontario, N5W 6A2

  • Centricity Research Mirabel Multispecialty

    Mirabel, Quebec, J7J 2K8

  • Recherche GCP Research

    Montreal, Quebec, H1Y 3H5

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

  • Centricity Research Toronto Manna Multispecialty

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOSE-RANGING, DOSE-FINDING, UMBRELLA STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08653945 AND PF-08653944, ALONE OR IN COMBINATION, IN ADULTS WITH OVERWEIGHT OR OBESITY (SOLIS-1)

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).

Being tested
PF-08653945, PF-08653944, Placebo
Keywords
Overnutrition, Nutrition Disorders, Nutritional and Metabolic Diseases, Body Weight, Obesity, Overweight, GLP-1RA, Amylin, DACRA
Medical subject headings
Overweight, Obesity, Overnutrition, Nutrition Disorders, Nutritional and Metabolic Diseases, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08653945Drug

    Subcutaneous Injection

  • PF-08653944Drug

    Subcutaneous Injection

  • PlaceboDrug

    Subcutaneous Injection

Study groups in NCT07575932
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants receive subcutaneous injections of PF-08653945 or placebo.
Receives: Drug: PF-08653945; Drug: Placebo
Cohort 2ExperimentalParticipants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo.
Receives: Drug: PF-08653945; Drug: PF-08653944; Drug: Placebo
Cohort 3ExperimentalParticipants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo.
Receives: Drug: PF-08653945; Drug: PF-08653944; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in body weight

    Measured: Baseline (Week 0) to Week 48

Secondary outcomes (8)

  1. Percent change from baseline in body weight

    Measured: Baseline (Week 0) to Week 60

  2. Change from baseline in body weight

    Measured: Baseline (Week 0) to Week 48 and Week 60

  3. Percentage of participants who achieve ≥5% of body weight reduction from baseline

    Measured: Baseline (Week 0) to Week 48 and Week 60

  4. Percentage of participants who achieve ≥10% of body weight reduction from baseline

    Measured: Baseline (Week 0) to Week 48 and Week 60

  5. Percentage of participants who achieve ≥15% of body weight reduction from baseline

    Measured: Baseline (Week 0) to Week 48 and Week 60

  6. Percentage of participants who achieve ≥20% of body weight reduction from baseline

    Measured: Baseline (Week 0) to Week 48 and Week 60

  7. Percentage of participants who achieve ≥25% of body weight reduction from baseline

    Measured: Baseline (Week 0) to Week 48 and Week 60

  8. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Measured: Up to Week 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start11 May 2026
  3. Primary completion4 Aug 2027 (estimated)
  4. Study completion5 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
940 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575932
Sponsor's protocol ID
C6511002
Other IDs
SOLIS-1
Acronym
SOLIS-1
Status last verified
Oct 2026
First submitted
4 May 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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