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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Pfizer

NCT ID: NCT07400653

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
PF-08653944 (drug), Placebo (other)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
PF-08653944 — drug: By Subcutaneous Injection · Placebo — other: By Subcutaneous Injection
Patient visit burden
"During this time, they will have about 14 study visits at the site and 5 over the phone." (as stated by sponsor)
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,078
Started
2026-02-24
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for obesity
  • • Phase3 - 1,078 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with obesity

Where?

  • • Hendon - Civia Health Sunderland
  • • Glasgow - FutureMeds Glasgow McCafferty House
  • • Bellshill - Synexus Glasgow Clinical Research Centre
  • • Birmingham - FutureMeds Birmingham
  • • +19 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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. 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.

ObesityOverweight and/or ObesityOverweightDiabetes, Type 2Type 2 Diabetes

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Provision of signed and dated agreement to take part 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...
  • ✓Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at...

Who cannot take part

  • ✗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
See the full criteria
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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

Where Is This Study? (23 UK sites)

Civia Health Sunderland

Hendon SR1 1PB, United Kingdom

FutureMeds Glasgow McCafferty House

Glasgow G20 7BE, United Kingdom

Synexus Glasgow Clinical Research Centre

Bellshill ML4 3NJ, United Kingdom

FutureMeds Birmingham

Birmingham B21 9RY, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Civia Health_Boots Birmingham

Birmingham B4 7TA, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

FutureMeds Liverpool

Bromborough CH62 6EE, United Kingdom

Synexus Midlands Clinical Research Centre

Edgbaston B16 8QQ, United Kingdom

Panthera Biopartners Limited - Enfield

Enfield EN3 4GS, United Kingdom

Panthera Biopartners Limited - Glasgow

Glasgow G51 4RY, United Kingdom

Bodyline Medical Clinic, Crosby Civia Health

Liverpool L22 4QQ, United Kingdom

FutureMeds London

London NW10 2PB, United Kingdom

Synexus Manchester Clinical Research Centre

Manchester M15 6SE, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Kiltearn Medical Centre

Nantwich CW5 5NX, United Kingdom

FutureMeds Newcastle

Newcastle upon Tyne NE6 1SG, United Kingdom

Civia Health_Boots Nottingham

Nottingham NG1 3QS,, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Panthera Biopartners Limited - Preston

Preston PR2 9QB, United Kingdom

Panthera Biopartners Limited - Rochdale

Rochdale OL11 4AU, United Kingdom

Ashfields Primary Care Centre

Sandbach CW11 1EQ, United Kingdom

Panthera Biopartners Limited - Sheffield

Sheffield S2 5FX, United Kingdom

Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Bodyline Medical Clinic, St Helens Civia Health

St Helens WA9 1AF, United Kingdom

FutureMeds Teesside

Stockton-on-Tees TS19 8PE, United Kingdom

Panthera Biopartners Limited - York

York YO24 4LJ, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09