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

JRCT ID: jRCT2031200422

Registered date:14/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 13/02/2021
• Target sample size: 420
• Countries of recruitment: Canada,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Placebo
4 matching placebo tablets taken twice daily

Drug: PF-06882961
Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg) achieved through 1-week titration steps (standard titration) or 3 active target dose levels (120, 160 or 200 mg) achieved through 2-week titration steps (slow titration), taking 4 tablets twice daily

Outcome(s)

Primary Outcome

Primary Outcome Measures :
1.Percent change from baseline in body weight [ Time Frame: Baseline, Week 26 (End of Treatment) ]

Secondary Outcome

Secondary Outcome Measures :
1.Body weight loss of greater than or equal to 5% [ Time Frame: Baseline, Week 26 (End of Treatment) ]
2.Percent change from baseline in body weight [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18 and 22 ]
3.Absolute change from baseline in waist circumference [ Time Frame: Baseline, Week 26 (End of Treatment) ]
4.Absolute change from baseline in waist-to-hip ratio [ Time Frame: Baseline, Week 26 (End of Treatment) ]
5.Absolute change from baseline in hemoglobin A1c [ Time Frame: Baseline, Week 16 and 26 ]
6.Absolute change from baseline in fasting plasma glucose [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18, 22 and 26 ]
7.Incidence of treatment emergent adverse events (AEs and SAEs) [ Time Frame: Baseline up to Week 31 ]
8.Incidence of treatment emergent clinically significant laboratory abnormalities [ Time Frame: Baseline up to Week 28 ]
9.Incidence of treatment emergent clinically significant vital sign abnormalities [ Time Frame: Baseline up to Week 28 ]
10.Incidence of treatment emergent clinically significant electrocardiogram (ECG) abnormalities [ Time Frame: Baseline up to Week 28 ]
11.Number of participants with categorical scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline up to Week 28 ]
12.Number of participants with categorical scores on the Patient Health Questionniare-9 (PHQ-9) [ Time Frame: Baseline up to Week 28 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT04707313