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RecruitingPHASE3INTERVENTIONAL

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

This important study is testing a new medicine called PF-08653944 for adults who are overweight or have obesity, alongside type 2 diabetes. The main goal is to find out if this medicine can safely help people lose weight. Being overweight or obese means carrying too much body weight, and type 2 diabetes means having too much sugar in your blood. The medicine is given as a weekly injection under the skin. Participants will learn how to give themselves this injection at home. Some people in the study will receive the active medicine, while others will receive a 'placebo', which looks like the medicine but contains no active ingredients. This helps researchers compare the effects accurately. The study lasts about 21 months and involves regular check-ups.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
999
Start
24 Feb 2026
Estimated completion
16 May 2028

What is this study about?

This study is about a new medicine (called PF-08653944) for adults who have both overweight or obesity and type 2 diabetes. Many people in the UK live with these conditions, and finding new ways to help manage them is really important. Being overweight or obese means having excess body fat, which can affect your health in many ways. Type 2 diabetes is a condition where your body either doesn't make enough insulin or doesn't use it properly, leading to high sugar levels in your blood.

The main aim of this study is to discover if this new medicine can safely help people living with these conditions to lose weight. The researchers also want to understand any effects the medicine might have on the body. If the medicine proves to be safe and effective, it could potentially offer a new treatment option in the future.

To make sure the study gives reliable results, some participants will receive the active study medicine, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but contains no active ingredients. This method helps the researchers compare the experiences of both groups to see if any positive changes are truly due to the medicine being tested.

Key takeaways

  • This study is for adults with overweight/obesity and type 2 diabetes.
  • It tests a new medicine given as a weekly injection for weight loss and safety.
  • Some participants will receive a placebo (no active medicine).
  • The study involves regular visits to the clinic and phone check-ups.
  • It lasts for about 21 months.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over. You must be overweight or have obesity (your Body Mass Index, or BMI, needs to be 27 or higher). You also need to have type 2 diabetes that was diagnosed at least six months ago, with your blood sugar levels (HbA1c) in a specific range. Your diabetes treatment should have been stable for at least 90 days, meaning you can't be taking certain diabetes medicines like GLP-1 agonists or insulin.

It's important that you are willing and able to give yourself injections under the skin once a week (or have a caregiver help you) and check your blood sugar with finger-prick tests if needed. You also need to have tried to lose weight through diet at least once before.

You cannot join if you are pregnant or breastfeeding, or if you have type 1 diabetes or another type of diabetes not including type 2. If you've had severe low blood sugar recently, have uncontrolled high blood pressure, or have had weight loss surgery, you also won't be able to take part. Also, if you've recently taken other weight loss medications or received steroid treatment, you would not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a BMI of 27 or higher?
  3. Have you been diagnosed with type 2 diabetes for at least 6 months?
  4. Are you able and willing to give yourself weekly injections (or have help)?
  5. Have you tried losing weight through diet before?
  6. Are you NOT pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for about 21 months, which is just under two years. The main part of the treatment will involve giving yourself a weekly injection of the study medicine (or placebo) under the skin, usually in your belly. You'll be trained on how to do this safely at home. Throughout the study, you'll have about 14 visits to the study site for check-ups and assessments. You'll also have about 5 check-ups over the phone. These visits allow the study team to monitor your health, see how you're responding to the medicine, and check for any side effects.

Potential risks and benefits

Participating in this study might offer the potential benefit of losing weight and improving your health, but it's important to remember that not everyone will receive the active medicine. As with any medicine, there could be side effects or risks, though the study team will monitor you closely for these. You will be told more about potential side effects before you decide to join. It's crucial to understand that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (183)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • CenExel Anaheim Clinical Trials
    Verified postcode
    Anaheim, United States· Recruiting
  • Alliance Research Institute
    Verified postcode
    Canoga Park, United States· Recruiting
  • Core Healthcare Group
    Verified postcode
    Cerritos, United States· Recruiting
  • CenExel CNS - Collaborative Neuroscience Research
    Verified postcode
    Los Alamitos, United States· Recruiting
  • Cure Clinical Research
    Verified postcode
    Orange, United States· Recruiting
  • CenExel CIT
    Verified postcode
    Riverside, United States· Recruiting
  • CenExel Denver CO (Rocky Mountain Clinical Research)
    Verified postcode
    Englewood, United States· Recruiting
  • Miami Eye Institute
    Verified postcode
    Hollywood, United States· Recruiting
  • Research Centers of America
    Verified postcode
    Hollywood, United States· Recruiting
  • Future Medical Research (Civia Health)
    Verified postcode
    Longwood, United States· Recruiting
  • Advanced Clinical Research
    Verified postcode
    Miami, United States· Recruiting
  • Oviedo Medical Research
    Verified postcode
    Oviedo, United States· Recruiting

Common questions

What is type 2 diabetes?

Type 2 diabetes is a condition where your body has trouble controlling blood sugar levels, often because it doesn't use insulin properly.

What is a placebo?

A placebo looks like the study medicine but contains no active ingredients. It's used to compare against the real medicine.

How is the medicine given?

The medicine is given as a weekly injection under the skin, which you will learn to do yourself at home.

How long will the study last?

The total study will last for about 21 months.

Can I stop participating if I want to?

Yes, you can leave the study at any time and for any reason, and it won't affect your regular medical care.

How to find out more

Pfizer CT.gov Call Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Learn About the Study Medicine (PF-08653944) in P…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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