Overview

A 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

Status:
Active, not recruiting
Trial end date:
2022-03-19
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the efficacy, safety, tolerability and pharmacokinetics (PK) of PF-06882961 in adults with obesity. The first part of the study, Part A, consists of study treatment dosing in Weeks 1 to 16. The second part of the study, Part B, is planned such that participants in Part A will continue dosing from Weeks 17 through 26, contingent upon supportive data. The planned End of Treatment is expected to be Week 26. If Part B is not conducted, then End of Treatment will be Week 16.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0
kg/m2

- Stable body weight, defined as <5 kg change (per participant report) for 90 days
before visit 1

Exclusion Criteria:

- Any condition possibly affecting drug absorption

- Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of
diabetes

- History of myocardial infarction, unstable angina, arterial revascularization, stroke,
heart failure, or transient ischemic attack within 6 months prior to visit 1

- Any malignancy not considered cured

- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine
Neoplasia syndrome type 2 or suspected MTC

- History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any
history of chronic pancreatitis

- Symptomatic gallbladder disease

- Medical history or characteristics suggestive of genetic or syndromic obesity or
obesity induced by other endocrinological disorders

- History of major depressive disorder or other severe psychiatric disorders within the
last 2 years

- Any lifetime history of a suicide attempt

- Known medical history of active liver disease, including chronic active hepatitis B or
C, or primary biliary cirrhosis

- Known history of HIV

- Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or
equal to 100 mmHg (diastolic)

- Clinically relevant ECG abnormalities

- Positive urine drug screen

- Participation in a formal weight reduction program within 90 days prior to visit 1