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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05579977
Other study ID # C3991004
Secondary ID 2022-002834-15
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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