A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

Pfizer

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Placebo (Cohorts 1 and 2); Drug: Placebo (Cohort 3); Drug: PF-06882961 (Cohort 3); Drug: PF-06882961 (Cohorts 1 and 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04707313

C3421019

2020-001312-19 (EudraCT Number)

Details and patient eligibility

About

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood.

This study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening).

There are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls).

Enrollment: 630 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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630 participants in 13 patient groups, including a placebo group

Placebo (Cohorts 1 and 2)

Placebo Comparator group

Treatment:

Drug: Placebo (Cohorts 1 and 2)

PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)

Experimental group

Description:

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

PF-06882961 80 mg BID, 1-week titration (Cohort 1)

Experimental group

Description:

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

PF-06882961 120 mg BID, 1-week titration (Cohort 1)

Experimental group

Description:

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

PF-06882961 160 mg BID, 1-week titration (Cohort 1)

Experimental group

Description:

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

PF-06882961 200 mg BID, 1-week titration (Cohort 1)

Experimental group

Description:

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2)

Experimental group

Description:

The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2)

Experimental group

Description:

The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2)

Experimental group

Description:

The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID.

Treatment:

Drug: PF-06882961 (Cohorts 1 and 2)

Placebo (Cohort 3)

Placebo Comparator group

Treatment:

Drug: Placebo (Cohort 3)

PF-06882961 80 mg BID, 4-week titration (Cohort 3)

Experimental group

Description:

The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID.

Treatment:

Drug: PF-06882961 (Cohort 3)

PF-06882961 140 mg BID, 4-week titration (Cohort 3)

Experimental group

Description:

The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID.

Treatment:

Drug: PF-06882961 (Cohort 3)

PF-06882961 200 mg BID, 4-week titration (Cohort 3)

Experimental group

Description:

The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID.

Treatment:

Drug: PF-06882961 (Cohort 3)