A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PF-08653944
DrugBy Subcutaneous Injection
Placebo
Other interventionBy Subcutaneous Injection
Treatment groups
999 Participants
are divided into 4 treatment groupsGroup A: Treatment Arm 1Experimental treatment 1 intervention
Group B: Treatment Arm 2Experimental treatment 1 intervention
Group C: Treatment Arm 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change from baseline in body weight
Time frame
Baseline, Week 64Secondary outcomes
1
Change from baseline in body weight
Time frame
Baseline, Week 64 and 842
Change in HbA1c (%) from baseline
Time frame
Baseline, Week 64 and 843
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time frame
Baseline, Week 64 and 844
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time frame
Baseline, Week 64 and 84 Source ClinicalTrials.gov