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A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity
EU CTIS ID: 2024-513679-42-00
What this study is testing
To compare the effect of multiple dose levels of PF-07976016 versus placebo on body weight in participants with obesity on a background of liraglutide.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or non-pregnant, non-breastfeeding female, 18 (or the minimum age of consent in accordance with local regulations) to 74 years of age at Visit 1.
- BMI ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as <5 kg change (per participant report) in the 12 weeks before Visit 1.
- Eligible and willing to receive liraglutide (Saxenda®) according to prescribing information, including self-administration of daily injections.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures including maintaining a dosing diary.
You likely can't join if
- Diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes.
- Use of any prohibited prior or concomitant medication(s), including GLP-1R agonists or other weight loss medication within 12 weeks before Visit 1.
- Presence of specified abnormalities on clinical laboratory tests at Visit 1.
- Any condition possibly affecting drug absorption.
- History of gastroparesis.
- History of acute pancreatitis within 6 months before Visit 1 or any history of chronic pancreatitis.
See the full eligibility criteria
- Male or non-pregnant, non-breastfeeding female, 18 (or the minimum age of consent in accordance with local regulations) to 74 years of age at Visit 1.
- BMI ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as <5 kg change (per participant report) in the 12 weeks before Visit 1.
- Eligible and willing to receive liraglutide (Saxenda®) according to prescribing information, including self-administration of daily injections.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures including maintaining a dosing diary.
- Diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes.
- Use of any prohibited prior or concomitant medication(s), including GLP-1R agonists or other weight loss medication within 12 weeks before Visit 1.
- Presence of specified abnormalities on clinical laboratory tests at Visit 1.
- Any condition possibly affecting drug absorption.
- History of gastroparesis.
- History of acute pancreatitis within 6 months before Visit 1 or any history of chronic pancreatitis.
- Symptomatic gallbladder disease.
- History, within 6 months before Visit 1, of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association (NYHA) Functional Class II-IV heart failure, or transient ischemic attack.
- Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator’s judgement.
- Known intolerance or hypersensitivity to liraglutide or other GLP-1R agonist(s), or any ingredients in the study interventions.
- Presence, or history within the 2 years before Visit 1, of unstable major depressive disorder or any history of severe psychiatric disorder.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.