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

• Sponsor: Pfizer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04707313
• Collaborator: (none)
• Enrollment: 499
• Locations: 41
• Arms: 9
• Anticipated Duration (Months): 22
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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. The planned End of Treatment is expected to be Week 26.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Placebo; Drug: PF-06882961	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 499 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 26-WEEK, PHASE 2B, 2-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
• Actual Study Start Date: Jan 29, 2021
• Anticipated Primary Completion Date: Oct 27, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; 4 matching placebo tablets taken twice daily
Experimental: PF-06882961 40 milligrams (mg) twice daily (BID), standard titration The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID. Titration steps include: 10 mg BID, 20 mg BID, and 40 mg BID.	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
Experimental: PF-06882961 80 mg BID, standard titration The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID.	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
Experimental: PF-06882961 120 mg BID, standard titration The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID.	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
Experimental: PF-06882961 160 mg BID, standard titration The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID, 120 mg BID, 140 mg BID and 160 mg BID.	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
Experimental: PF-06882961 200 mg BID, standard titration The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID, 120 mg BID, 140 mg BID, 160 mg BID, 180 mg BID and 200 mg BID.	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
Experimental: PF-06882961 120 mg BID, slow titration The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID.	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
Experimental: PF-06882961 160 mg BID, slow titration The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg, 100 mg BID, 120 mg BID, 140 mg BID and 160 mg BID.	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
Experimental: PF-06882961 200 mg BID, slow titration The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID, 120 mg BID, 140 mg BID, 160 mg BID, 180 mg BID and 200 mg BID.	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 Measures

Primary Outcome Measures

1. Percent change from baseline in body weight [Baseline, Week 26 (End of Treatment)]

Secondary Outcome Measures

1. Body weight loss of greater than or equal to 5% [Baseline, Week 26 (End of Treatment)]

2. Percent change from baseline in body weight [Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18 and 22]

3. Absolute change from baseline in waist circumference [Baseline, Week 26 (End of Treatment)]

4. Absolute change from baseline in waist-to-hip ratio [Baseline, Week 26 (End of Treatment)]

5. Absolute change from baseline in hemoglobin A1c [Baseline, Week 16 and 26]

6. Absolute change from baseline in fasting plasma glucose [Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18, 22 and 26]

7. Incidence of treatment emergent adverse events (AEs and SAEs) [Baseline up to Week 31]

8. Incidence of treatment emergent clinically significant laboratory abnormalities [Baseline up to Week 28]

9. Incidence of treatment emergent clinically significant vital sign abnormalities [Baseline up to Week 28]

10. Incidence of treatment emergent clinically significant electrocardiogram (ECG) abnormalities [Baseline up to Week 28]

11. Number of participants with categorical scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline up to Week 28]

12. Number of participants with categorical scores on the Patient Health Questionniare-9 (PHQ-9) [Baseline up to Week 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group, LLC	Anniston	Alabama	United States	36207
2	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
3	National Research Institute - Wilshire	Los Angeles	California	United States	90057
4	Alliance for Multispecialty Research, LLC	Coral Gables	Florida	United States	33134
5	Optimus U Corporation	Miami	Florida	United States	33125
6	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32801
7	ForCare Clinical Research	Tampa	Florida	United States	33613
8	Clinical Investigation Specialists	Gurnee	Illinois	United States	60031
9	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
10	Velocity Clinical Research, Valparaiso	Valparaiso	Indiana	United States	46383
11	Cotton O'Neil Clinical Research Center	Topeka	Kansas	United States	66606
12	L-MARC Research Center	Louisville	Kentucky	United States	40213
13	ActivMed Practices & Research, LLC	Methuen	Massachusetts	United States	01844
14	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
15	PMG Research of Hickory, LLC	Hickory	North Carolina	United States	28601
16	PMG Research of Raleigh, LLC	Raleigh	North Carolina	United States	27609
17	PMG Research of Salisbury, LLC	Salisbury	North Carolina	United States	28144
18	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
19	Lillestol Research LLC	Fargo	North Dakota	United States	58104
20	Velocity Clinical Research, Inc.	Cleveland	Ohio	United States	44122
21	Clinical Trials of South Carolina	Moncks Corner	South Carolina	United States	29461
22	Coastal Carolina Research Center	North Charleston	South Carolina	United States	29405
23	Palmetto Clinical Research	Summerville	South Carolina	United States	29485
24	Palmetto Primary Care Physicians (Sub-I physicals only)	Summerville	South Carolina	United States	29485
25	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee	United States	37620
26	PMG Research, Inc. d/b/a PMG Research of Knoxville	Knoxville	Tennessee	United States	37938
27	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee	United States	38119
28	Rivergrove Medical Clinic	Winnipeg	Manitoba	Canada	R2V 4W3
29	Aggarwal and Associates Limited	Brampton	Ontario	Canada	L6T 0G1
30	Milestone Research , Inc	London	Ontario	Canada	N5W 6A2
31	Manna Research Toronto	Toronto	Ontario	Canada	M9W 4L6
32	Ecogene-21	Chicoutimi	Quebec	Canada	G7H 7K9
33	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec	Canada	J1L 0H8
34	Centre de Recherche Saint-Louis	Quebec		Canada	G1W4R4
35	Alpha Recherche Clinique	Quebec		Canada	G2J 0C4
36	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka	Japan	565-0853
37	Tokyo Center Clinic	Chuo-ku	Tokyo	Japan	103-0028
38	Fukuwa Clinic	Chuo-ku	Tokyo	Japan	104-0031
39	Medical Corporation Heishinkai ToCROM Clinic	Shinjuku-ku	Tokyo	Japan	160-0008
40	China Medical University Hospital	Taichung City		Taiwan	40447
41	National Cheng Kung University Hospital	Tainan		Taiwan	704

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04707313
• Other Study ID Numbers: C3421019; 2020-001312-19
• First Posted: Jan 13, 2021
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Weight loss
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Jun 30, 2022