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ObesityPhase 3NCT07400653

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)

A Phase 3 study testing PF-08653944 in people with Obesity and Overweight and/or Obesity, run by Pfizer at 180 sites in 11 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

The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight and/or Obesity, Overweight
What is being tested?
PF-08653944
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,078 participants
Where
180 sitesin 11 countries
Study dates
24 Feb 2026to 16 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Provision of signed and dated informed consent form (ICF)
  • Male or female adults, aged ≥18 years
  • Have a BMI at Screening of ≥27.0 kg/m2
  • Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria
  • Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with:
  • --Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin
Show all 10Show fewer
  • Participants must be motivated and willing to:
  • Self-inject study medication (or be aided by caregiver if needed),
  • Perform finger-stick glucose monitoring as required.
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Who cannot join

  • Female who is breastfeeding, or who is pregnant
  • Unwilling or unable to follow contraceptive requirements
  • Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM.
  • Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening
  • Poorly controlled hypertension
  • Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
  • Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss
  • Are receiving or have received within 3 months prior to screening chronic (>2 weeks or 14 days) systemic glucocorticoid therapy

Trial locations and contacts

180 sites in 11 countries.

180 sites in 11 countries

United States55 sites

  • Amarillo Medical Specialists LLP

    Amarillo, Texas, 79124

  • CenExel Anaheim Clinical Trials

    Anaheim, California, 92801

  • DelRicht Research

    Atlanta, Georgia, 30329

  • Forum Austin (Civia Health)

    Austin, Texas, 78578

  • Pantheon Clinical Research

    Bountiful, Utah, 84010

  • Alliance Research Institute

    Canoga Park, California, 91304

  • Forum Health_Cary (Civia)

    Cary, North Carolina, 27511

  • Core Healthcare Group

    Cerritos, California, 90703

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030

  • Eximia EquiHealth Research

    Durham, North Carolina, 27704

  • GLRI El Paso Research

    El Paso, Texas, 79936

  • Upgrade Performance Institute

    Elkhorn, Nebraska, 68022

  • CenExcel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113

  • CenExel Denver CO (Rocky Mountain Clinical Research)

    Englewood, Colorado, 80113

  • AMR Clinical

    Fort Myers, Florida, 33912

  • Pedro P. Ylisastigui, MD

    Fort Myers, Florida, 33912

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Civia Health Goodlettsville

    Goodlettsville, Tennessee, 37072

  • Tribe Clinical Research LLC.- Greenville

    Greenville, South Carolina, 29607

  • Private Practice Adjacent to For Eyes Optical

    Hialeah, Florida, 33014

  • Sahana Optometry PLLC dba Family Eye Wellness

    Holly Springs, North Carolina, 27540

  • Miami Eye Institute

    Hollywood, Florida, 33024

  • Research Centers of America

    Hollywood, Florida, 33024

  • Cardiovascular Specialists of Willowbrook

    Houston, Texas, 77070

  • Civia Health Nashville

    La Vergne, Tennessee, 37086

  • Neuro-Sight Vision Care

    Lakewood, Colorado, 80226

  • Future Medical Research (Civia Health)

    Longwood, Florida, 32750

  • CenExel CNS - Collaborative Neuroscience Research

    Los Alamitos, California, 90720

  • DexaFit Los Alamitos

    Los Alamitos, California, 90720

  • Retina Consultants of Orange County

    Los Alamitos, California, 90720

  • Patient First Clinical Trials (PFCTRIALS)

    Lutherville, Maryland, 21093

  • Hassman Research Institute

    Marlton, New Jersey, 08053

  • Advanced Clinical Research

    Miami, Florida, 33156

  • Indago Research & Health Center, Inc

    Miami Lakes, Florida, 33016

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • Quality Clinical Research Inc

    Omaha, Nebraska, 68114

  • Eye Consultants PC

    Omaha, Nebraska, 68124

  • Cure Clinical Research

    Orange, California, 92866

  • Optimal Research Sites, LLC

    Orange City, Florida, 32763

  • Oviedo Medical Research

    Oviedo, Florida, 32765

  • Rolling Oaks Radiology -Palms

    Oxnard, California, 93036

  • Primary clinical Research

    Papillion, Nebraska, 68046

  • Eximia Research - NC, LLC

    Raleigh, North Carolina, 27607

  • ERA Health Research

    Redmond, Washington, 98052

  • Dallas Clinical Research Center (Pillar Clinical Research)

    Richardson, Texas, 75080

  • Clinical Innovations, Inc dba CITrials

    Riverside, California, 92506

  • CenExel Salt Lake City UT (JBR Clinical Research)

    Salt Lake City, Utah, 84107

  • Murray Vision Center PC

    Salt Lake City, Utah, 84107

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405

  • Tribe Clinical Research LLC. - Spartanburg

    Spartanburg, South Carolina, 29301

  • DelRicht Research

    Springfield, Missouri, 65807

  • CenExel FCR - ForCare Clinical Research

    Tampa, Florida, 33613

  • Lundquist Institute for Biomedical Innovation at Harbor- UCLA Medical Center

    Torrance, California, 90502

  • Access Eye Institute

    Westlake Village, California, 91361

Other trials in United States

Poland26 sites

  • Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik

    Bialystok, 15-351

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85-231

  • Centrum medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Pratia Chojnice

    Chojnice, 89-600

  • Synexus Polska Sp. z o.o., Oddzial w Czestochowie

    Częstochowa, 42-202

  • Synexus Polska Sp z o.o.

    Gdansk, 80-382

  • Centrum Badan Klinicznych PI-House Sp. z o.o.

    Gdansk, 80-546

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-537

  • Synexus Polska Sp. Z O.O. Oddzial W Katowicach

    Katowice, 40-040

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Santa Familia PTG Lodz

    Lodz, WOJ Lodzkie, 90-302

  • Synexus Polska Sp. z o.o., Oddzial w Lodzi

    Lodz, 90-127

  • Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna

    Lodz, 90-338

  • Ekamed Sp. z o. o.

    Lublin, 20-718

  • FutureMeds Olsztyn

    Olsztyn, 10-165

  • Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych

    Oświęcim, 32-600

  • IRMED

    Piotrkow Trybunalski, 97-300

  • Trialmed CRS

    Piotrkow Trybunalski, 97-300

  • Synexus Polska Sp. z o.o., Oddział w Poznaniu

    Poznan, 60-702

  • ETG Siedlce

    Siedlce, 08-110

  • Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych

    Tarnów, 33-100

  • Instytut Diabetologii.sp.z.o.o.

    Warsaw, 02-117

  • Synexus Polska Sp. z o.o., Oddzial w Warszawie

    Warsaw, 02-672

  • Etg Warszawa

    Warsaw, 02-677

  • Synexus Polska Sp. z o.o., Oddział we Wrocławiu

    Wroclaw, 50-381

Other trials in Poland

United Kingdom21 sites

  • Synexus Glasgow Clinical Research Centre

    Bellshill, ML4 3NJ

  • FutureMeds Birmingham

    Birmingham, B21 9RY

  • Civia Health_Boots Birmingham

    Birmingham, B4 7TA

  • Southmead Hospital

    Bristol, BS10 5NB

  • FutureMeds Liverpool

    Bromborough, CH62 6EE

  • Synexus Midlands Clinical Research Centre

    Edgbaston, B16 8QQ

  • Panthera Biopartners Limited - Enfield

    Enfield, EN3 4GS

  • FutureMeds Glasgow McCafferty House

    Glasgow, Scotland, G20 7BE

  • Panthera Biopartners Limited - Glasgow

    Glasgow, G51 4RY

  • Civia Health Sunderland

    Hendon, CITY of Sunderland, SR1 1PB

  • FutureMeds London

    London, NW10 2PB

  • Synexus Manchester Clinical Research Centre

    Manchester, M15 6SE

  • Kiltearn Medical Centre

    Nantwich, CW5 5NX

  • FutureMeds Newcastle

    Newcastle upon Tyne, NE6 1SG

  • Civia Health_Boots Nottingham

    Nottingham, NG1 3QS,

  • Panthera Biopartners Limited - Preston

    Preston, PR2 9QB

  • Panthera Biopartners Limited - Rochdale

    Rochdale, OL11 4AU

  • Ashfields Primary Care Centre

    Sandbach, CW11 1EQ

  • Panthera Biopartners Limited - Sheffield

    Sheffield, S2 5FX

  • FutureMeds Teesside

    Stockton-on-Tees, TS19 8PE

  • Panthera Biopartners Limited - York

    York, YO24 4LJ

Other trials in United Kingdom

Germany16 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • FutureMeds Berlin

    Berlin, 10629

  • Velocity Clinical Research Germany

    Berlin, 10787

  • Klinische Forschung Dresden GmbH / Pratia

    Dresden, 01069

  • Medizentrum Essen Borbeck

    Essen, 45355

  • Praxis am Markt - Dr. Bernd Becker

    Essen, 45355

  • Klinische Forschung Hamburg GmbH / Pratia

    Hamburg, 20253

  • Diabeteszentrum Hamburg-West

    Hamburg, 22607

  • Praxis Reinfeld Mitte

    Holstein, 23858

  • Klinische Forschung Karlsruhe GmbH / Pratia Germany

    Karlsruhe, 76137

  • Studienzentrum FMZ Radowsky

    Leipzig, Saxony, 04179

  • CDG Studienambulanz Hartard

    Munich, Bavaria, 80809

  • Gemeinschaftspraxis Dres. H.Kittner und K.Hartig

    Naunhof, 04683

  • FutureMeds Frankfurt/Offenbach

    Offenbach, 63065

  • Zentrum für klinische Forschung Allgäu-Oberschwaben

    Wangen, 88239

  • Medislim GmbH

    Weinheim, 69469

Other trials in Germany

Bulgaria14 sites

  • MHAT Botevgrad

    Botevgrad, 2140

  • Medical Center 4 Life EOOD, Burgas

    Burgas, 8018

  • Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)

    Dobrich, 9300

  • Medical Center New Polyclinic Gabrovo Ltd.

    Gabrovo, 5300

  • Medical Center Zdrave 1

    Kozloduy, 3320

  • MHAT Sveta Karidad EAD

    Plovdiv, 4004

  • Medical Center Futuremeds EOOD

    Plovdiv

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, 1431

  • Medical Center Hera EOOD

    Sofia, 1710

  • Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD

    Stara Zagora, 6000

  • Medical Center - Clinic Nova EOOD

    Varna, 9020

  • Medical Centre "Pratia Clinic" EOOD

    Varna, 9020

  • MC Nevromedics Ltd.

    Veliko Tarnovo, 5005

  • Medical Center Berbatov

    Yambol, 8600

Other trials in Bulgaria

Romania11 sites

  • Minimed S.R.L.

    Bacau, 600274

  • Futuremeds S.R.L., Brasov

    Brasov, 500388

  • Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)

    Bucharest, 011053

  • Institutul National de Endocrinologie "C.I. Parhon"

    Bucharest, 011863

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Fundatia Dr Victor Babes

    Bucharest, 30303

  • Futuremeds S.R.L., Craiova

    Craiova, 200115

  • Futuremeds S.R.L., Galati

    Galati, 800183

  • Centru Medical "GRANDMED"

    Oradea, 410032

  • Sc Gensan Srl/Policlinica Astra

    Sibiu, 550371

  • Centrul Medical Mediab - Mediab Srl

    Târgu Mureş, 540142

Other trials in Romania

Argentina9 sites

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • CEDIC

    Buenos Aires, C1060

  • Centro Medico Viamonte

    Buenos Aires

  • Clinica Privada Velez Sarsfield

    Córdoba, 5000

  • Instituto de Investigaciones Clinicas Cordoba

    Córdoba, X5000AAW

  • CIDIM

    Córdoba, X5000AVE

  • CIPADI - Centro Integral de Prevencion Y Atencion en Diabetes

    Godoy Cruz, M5501ARP

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, T4000AXL

  • Instituto Medico Catamarca (IMEC)

    Santa Fe, S2000

Other trials in Argentina

Spain9 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, 41950

  • Futuremeds Spain Cadiz

    Chiclana de la Frontera, 11139

  • Futuremeds Spain Madrid

    Madrid, 28003

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Virgen del Camino

    Sanlúcar de Barrameda, 11540

  • Nuevas Tecnologías en Diabetes y Endocrinología S.L.

    Seville, 41003

  • Futuremeds Spain Sevilla

    Seville, 41012

  • Ecg Médica S.L.

    Valencia, 46015

Other trials in Spain

Slovakia8 sites

  • DIABEDA s.r.o.

    Bratislava, 831 06

  • Medispektrum s.r.o.

    Bratislava, 85101

  • Poliklinika Váš Lekár

    Bratislava - Ružinov, 91109

  • Cardio D&R Košice

    Košice, 040 22

  • Medical group Kosice s.r.o.

    Košice, 04001

  • Tatratrial s.r.o.

    Rožňava, 048 01

  • JAL s.r.o.

    Trnava, 91701

  • Medivasa s.r.o

    Žilina, 010 01

Other trials in Slovakia

Czechia7 sites

  • Diacentrum Brandys n.L.

    Brandys Nad Lebem, 25001

  • Edumed s.r.o.

    Náchod, 54701

  • CCR Ostrava

    Ostrava, 702 00

  • Pratia Pardubice

    Pardubice, 53002

  • Fakultní nemocnice Královské Vinohrady

    Prague, 100 34

  • Synexus/Trialmed Prague

    Prague, 120 00

  • ResTrial s.r.o.

    Prague, 18100

Other trials in Czechia

Canada4 sites

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • The Wharton Medical Clinic Clinical Trials Inc

    Hamilton, Ontario, L8L 5G8

  • Centricity Research Mirabel Multispecialty (Centricity Research)

    Mirabel, Quebec, J7J 2K8

  • LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)

    Toronto, Ontario, M4G 3E8

Other trials in Canada

About this study

Official title: EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)

The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood.

The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week.

Read more

About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective.

People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.

Being tested
PF-08653944, Placebo
Keywords
Overnutrition, Nutrition Disorders, Nutritional and Metabolic Diseases, Body Weight, Signs and Symptoms, Pathological Conditions, Signs and Symptoms, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Overweight, Obesity, Diabetes Mellitus, Type 2
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2, Overnutrition, Nutrition Disorders, Nutritional and Metabolic Diseases, Body Weight, Signs and Symptoms

What participants receive

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

  • PF-08653944Drug

    Also called MET097

    By Subcutaneous Injection

  • PlaceboOther

    By Subcutaneous Injection

Study groups in NCT07400653
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive matching placebo by Subcutaneous Injection.
Receives: Other: Placebo
Treatment Arm 1ExperimentalParticipants will receive PF-08653944 by Subcutaneous Injection.
Receives: Drug: PF-08653944
Treatment Arm 2ExperimentalParticipants will receive PF-08653944 by Subcutaneous Injection.
Receives: Drug: PF-08653944
Treatment Arm 3ExperimentalParticipants will receive PF-08653944 by Subcutaneous Injection.
Receives: Drug: PF-08653944

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 64

Secondary outcomes (32)

  1. Change from baseline in body weight

    Measured: Baseline, Week 64 and 84

  2. Change in HbA1c (%) from baseline

    Measured: Baseline, Week 64 and 84

  3. Percentage of Participants achieving ≥5% of body weight reduction from baseline

    Measured: Baseline, Week 64 and 84

  4. Percentage of Participants achieving ≥10% of body weight reduction from baseline

    Measured: Baseline, Week 64 and 84

  5. Percentage of Participants achieving ≥15% of body weight reduction from baseline

    Measured: Baseline, Week 64 and 84

  6. Percentage of Participants achieving ≥20% of body weight reduction from baseline

    Measured: Baseline, Week 64 and 84

  7. Change from baseline in Fasting triglycerides

    Measured: Baseline, Week 64 and 84

  8. Change from baseline in Non-high-density lipoprotein cholesterol (non-HDL-C)

    Measured: Baseline, Week 64 and 84

  9. Change from baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 64 and 84

  10. Change from baseline in Short Form 36 health survey (SF-36) physical function domain score

    Measured: Baseline, Week 64 and 84

  11. Percent change from baseline in body weight

    Measured: Baseline, Week 84

  12. Change from baseline in waist circumference

    Measured: Baseline, Week 64 and 84

  13. Percentage of Participants Achieving HbA1c <7%

    Measured: Week 64 and Week 84

  14. Percentage of Participants Achieving HbA1c ≤6.5%

    Measured: Week 64 and Week 84

  15. Percentage of Participants Achieving HbA1c <5.7%

    Measured: Week 64 and Week 84

  16. Change from Baseline in Fasting Glucose

    Measured: Baseline, Week 64 and 84

  17. Change from Baseline in Fasting insulin

    Measured: Baseline, Week 64 and 84

  18. Change from baseline in Total Cholesterol

    Measured: Baseline, Week 64 and 84

  19. Change from baseline in Low-density lipoprotein cholesterol

    Measured: Baseline, Week 64 and 84

  20. Change from baseline in Very low-density lipoprotein cholesterol

    Measured: Baseline, Week 64 and 84

  21. Change from baseline in High-density lipoprotein cholesterol

    Measured: Baseline, Week 64 and 84

  22. Change from Baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline, Week 64 and 84

  23. Percent change from baseline in high-sensitivity C-reactive protein

    Measured: Baseline, Week 64 and 84

  24. Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)

    Measured: Baseline, Week 64 and 84

  25. Change from Baseline in Control of Eating Questionnaire (CoEQ)

    Measured: Baseline, Week 64 and 84

  26. Change from Baseline in Food Noise Questionnaire (FNQ)

    Measured: Baseline, Week 64 and 84

  27. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: Week 84

  28. Number of Participants with Serious adverse events (SAEs)

    Measured: Week 84

  29. Number of Participants with Adverse Events of Clinical Interest (AECIs)

    Measured: Week 84

  30. Number of Participants With Clinical Laboratory Abnormalities

    Measured: Week 84

  31. Number of participants with anti-drug antibodies (ADAs)

    Measured: Week 84

  32. Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944

    Measured: Week 84

Timeline

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

  1. First posted10 Feb 2026
  2. Study start24 Feb 2026
  3. Primary completion12 Oct 2027 (estimated)
  4. Study completion16 May 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,078 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07400653
Sponsor's protocol ID
C6491008
Other IDs
MET097-25-302, 2025-523975-48-00, VESPER-5, 2025
Status last verified
Oct 2026
First submitted
3 Feb 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-08653944 in people with Obesity and Overweight and/or Obesity, run by Pfizer at 180 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in United States, Poland, United Kingdom, Germany, Bulgaria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from baseline in body weight (time frame: Baseline, Week 64). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07400653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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