Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

Obesity Clinical Trial

Official title:

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05579977
• Other study ID #: C3991004
• Secondary ID: 2022-002834-15
• Status: Terminated
• Phase: Phase 2
• Start date: October 27, 2022
• Est. completion date: September 22, 2023

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study. Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 902
• Est. completion date: September 22, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

T2DM

• T2DM inadequately controlled with metformin
• BMI =23.0 kg/m2 (=20.0 kg/m2 in Japan)
• HbA1C of 7% to 10% (53-86 mmol/mol)
• FPG =270 mg/dL (15 mmol/L) Obesity
• BMI =30.0 kg/m2
• HbA1C =6.4% (47 mmol/mol)
• FPG =126 mg/dL (7 mmol/L)

Exclusion Criteria:

• Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)
• Use of pharmacological agents with approved indication for weight loss
• T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;
• Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score =15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS
• Clinically significant cardiovascular conditions
• Uncontrolled blood pressure
• Personal or within first-degree relative family history of MTC or MEN2
• Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
• Any of the following central lab results: Fasting C-peptide <0.8 ng/mL; ALT or AST =2.5x ULN; Direct bilirubin >ULN or T Bili >1.5x ULN except when participants have a history of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serum amylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

Drug:
• PF-07081532
Oral glucagon-like peptide-1 receptor agonist

Other:
• Placebo
No drug

Drug:
• Rybelsus
Oral Semaglutide

Locations

Country	Name	City	State
Bulgaria	MHAT Botevgrad	Botevgrad	Sofia
Bulgaria	Medical Centre "Asklepiy"	Dupnitsa	Kyustendil
Bulgaria	Medical Center Zdrave 1	Kozloduy	Vratsa
Bulgaria	Diagnostic Consultative Center Aleksandrovska	Sofia	Sofia (stolitsa)
Bulgaria	"Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD	Stara Zagora
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	Dawson Clinical Research	Guelph	Ontario
Canada	Milestone Research Inc.	London	Ontario
Canada	Manna Research Mirabel	Mirabel	Quebec
Canada	G A Research Associates	Moncton	New Brunswick
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Diex Recherche Quebec Inc.	Quebec
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario
Canada	Dr. M.B. Jones Inc.	Victoria	British Columbia
Canada	Diex Recherche Victoriavile Inc.	Victoriaville	Quebec
Czechia	EDUMED s.r.o.	Broumov	Kralovehradecky KRAY
Czechia	MUDr. Alena Vachova	Ceske Budejovice	Jihoceský KRAJ
Czechia	Agentura Science Pro	Olomouc
Czechia	Private Practice - Dr. Tomáš Brychta	Olomouc
Czechia	Kardiologicka a Angiologicka Ambulance	Ostrava	Ostrava Mesto
Czechia	EUC Klinika Praha	Prague
Czechia	Clinical Trials Service s.r.o.	Uherské Hradište	Zlínský KRAJ
Czechia	Clinical Trials Service s.r.o.	Uherske Hradiste
Hungary	DRC Gyógyszervizsgáló Központ	Balatonfüred	Veszprém
Hungary	ClinDiab Kft.	Budapest
Hungary	Belinus Orvosi és Számitástechnikai Bt	Debrecen	Hajdú-bihar
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Borbánya Praxis	Nyíregyháza, Borbánya	Szabolcs-szatmár-bereg
Hungary	CLINFAN Szolgáltató Kft	Szekszárd	Tolna
Japan	Seiwa Clinic	Adachi-ku	Tokyo
Japan	Seiwa Clinic	Adachi-ku	Tokyo
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Medical Corporation Chiseikai Tokyo Center Clinic	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	Shiraiwa Medical Clinic	Kashiwara	Osaka
Japan	Nakakinen clinic	Naka	Ibaraki
Japan	Medical Corporation Heishinkai ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Yokohama Minoru Clinic	Yokohama	Kanagawa
Japan	Yokohama Minoru Clinic	Yokohama
Poland	Zdrowie Osteo-Medic	Bialystok	Podlaskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	Gabinet Lekarski Malgorzata Jadwiga Saryusz-Wolska	Lódz
Poland	Oswiecimskie Centrum Badan Klinicznych	Oswiecim	Malopolskie
Poland	Centrum Zdrowia Metabolicznego Pawel Bogdanski	Poznan
Poland	KO-MED Centra Kliniczne Pulawy	Pulawy	Lubelskie
Poland	NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki	Ruda Slaska	Slaskie
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Puerto Rico	Latin Clinical Trial Center	San Juan
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Elligo Clinical Research Center	Austin	Texas
United States	Heritage Valley Multispecialty Group, Inc	Beaver	Pennsylvania
United States	Hassman Research Institute	Berlin	New Jersey
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	San Fernando Valley Health Institute	Canoga Park	California
United States	Trinity Clinical Research	Centreville	Alabama
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	Innovative Research of West Florida	Clearwater	Florida
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Velocity Clinical Research, Dallas	Dallas	Texas
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Anderson Medical Research	Fort Washington	Maryland
United States	Medication Management	Greensboro	North Carolina
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Medical Colleagues of Texas, LLP	Katy	Texas
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Catalina Research Institute, LLC	Montclair	California
United States	Healthstar Physicians	Morristown	Tennessee
United States	HealthStar Physicians, P.C.	Morristown	Tennessee
United States	Adult Medicine of Lake County	Mount Dora	Florida
United States	Alliance for Multispecialty Research, LLC	Norman	Oklahoma
United States	Tapia Internal Medicine Clinic	Paris	Texas
United States	Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)	Pittsburgh	Pennsylvania
United States	Empire Clinical Research	Pomona	California
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Chrysalis Clinical Research	Saint George	Utah
United States	Southwest Internal Medicine	Saint George	Utah
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Northeast Clinical Research of San Antonio	San Antonio	Texas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Evanston Premier Healthcare Research LLC	Skokie	Illinois
United States	Sugar Lakes Family Practice	Sugar Land	Texas
United States	Premier Research	Trenton	New Jersey
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Hungary,  Japan,  Poland,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM)		baseline, week 32
Primary	Placebo-adjusted, percent change from baseline in body weight at Week 32 in Obesity		baseline, week 32
Secondary	Proportion of participants who achieve HbA1C <7% (<53 mmol/mol) at Week 32 in T2DM		week 32
Secondary	Placebo-adjusted, change from baseline in FPG at Week 32 in T2DM		baseline, week 32
Secondary	Placebo-adjusted, percent change from baseline in body weight at Week 32 in T2DM		baseline, week 32
Secondary	Placebo-adjusted, change from baseline in HbA1C at Week 32 with Rybelsus in T2DM		baseline, week 32
Secondary	Proportion of participants achieving =5% body weight loss at Week 32 relative to baseline in Obesity		baseline, week 32
Secondary	Proportion of participants achieving =10% body weight loss at Week 32 relative to baseline in Obesity		Week 32
Secondary	Proportion of participants achieving=15% body weight loss at Week 32 relative to baseline in Obesity		Week 32
Secondary	Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity		baseline, week 32
Secondary	Placebo-adjusted, absolute change from baseline in waist-to hip ratio at Week 32 in Obesity		baseline, week 32
Secondary	Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Resistance at Week 32 in Obesity		baseline, week 32
Secondary	Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Sensitivity at Week 32 in Obesity		baseline, week 32
Secondary	To compare PF 07081532 to placebo in the number of participants reporting Adverse Events		week 36 and 48
Secondary	To compare PF 07081532 to placebo in the number of participants reporting Serious Adverse Events		week 36, week 48
Secondary	To compare PF 07081532 to placebo in the number of participants reporting Adverse Events leading to discontinuation		week 36, week 48
Secondary	To compare PF 07081532 to placebo in the number of participants reporting Hypoglycemia		Week 36, week 48
Secondary	To compare PF 07081532 to placebo in the number of participants with clinical laboratory abnormalities		Week 36, week 48
Secondary	To compare PF 07081532 to placebo in the number of participants with vital sign abnormalities		Week 36, Week 48
Secondary	To compare PF 07081532 to placebo in the number of participants with ECG abnormalities		Week 34, week 46
Secondary	Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity		Week 32 and 44

External Links

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