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