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

NCT05579977 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: C39910042022-002834-15
• Study Type: interventional
• Target: 902
• Locations: 8 countries
• Sites: 90

Brief 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.

Conditions

Diabetes Mellitus; Obesity

Keywords

Diabetes Mellitus; Obesity

Outcome Measures

Primary Outcomes (2)

• Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

  Baseline (result closest prior to dosing on Day 1), Week 32

• Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)

  Body weight was measured using a calibrated weighing scale.

  Baseline (result closest prior to dosing on Day 1), week 32

Secondary Outcomes (24)

• Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

  Baseline (result closest prior to dosing on Day 1), Week 32

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

  Baseline (result closest prior to dosing on Day 1), Week 32

• Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

  Baseline (result closest prior to dosing on Day 1), Week 32

• Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

  Baseline (result closest prior to dosing on Day 1), Week 32

• Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)

  Baseline (result closest prior to dosing on Day 1), Week 32

Other Outcomes (9)

• Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

  Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

• Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)

  Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

  Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

Study Arms (13)

PF-07081532 20 mg T2DM

EXPERIMENTAL

PF-07081532 20 mg daily in T2DM

Drug: PF-07081532

PF-07081532 40 mg T2DM

EXPERIMENTAL

PF-07081532 40 mg daily in T2DM

Drug: PF-07081532

PF-07081532 80 mg T2DM

EXPERIMENTAL

PF-07081532 80 mg daily in T2DM

Drug: PF-07081532

PF-07081532 160 mg T2DM

EXPERIMENTAL

PF-07081532 160 mg daily in T2DM

Drug: PF-07081532

PF-07081532 260 mg T2DM

EXPERIMENTAL

PF-07081532 260 mg daily in T2DM

Drug: PF-07081532

Placebo T2DM

PLACEBO COMPARATOR

Placebo daily in T2DM

Other: Placebo

PF-07081532 80 mg Obesity

EXPERIMENTAL

PF-07081532 80 mg daily in Obesity

Drug: PF-07081532

PF-07081532 140 mg Obesity

EXPERIMENTAL

PF-07081532 140 mg daily in Obesity

Drug: PF-07081532

PF-07081532 200 mg Obesity (Option 1)

EXPERIMENTAL

PF-07081532 200 mg daily in Obesity

Drug: PF-07081532

PF-07081532 200 mg Obesity (Option 2)

EXPERIMENTAL

PF-07081532 200 mg daily in Obesity

Drug: PF-07081532

PF-07081532 260 mg Obesity

EXPERIMENTAL

PF-07081532 260 mg daily in Obesity

Drug: PF-07081532

Rybelsus 14 mg T2DM

ACTIVE COMPARATOR

Semaglutide 14 mg daily in T2DM

Drug: Rybelsus

Placebo Obesity

PLACEBO COMPARATOR

Placebo in Obesity

Other: Placebo

Interventions

PF-07081532 DRUG

Oral glucagon-like peptide-1 receptor agonist

PF-07081532 140 mg Obesity; PF-07081532 160 mg T2DM; PF-07081532 20 mg T2DM; PF-07081532 200 mg Obesity (Option 1); PF-07081532 200 mg Obesity (Option 2); PF-07081532 260 mg Obesity; PF-07081532 260 mg T2DM; PF-07081532 40 mg T2DM; PF-07081532 80 mg Obesity; PF-07081532 80 mg T2DM

Placebo OTHER

No drug

Placebo Obesity; Placebo T2DM

Rybelsus DRUG

Oral Semaglutide

Rybelsus 14 mg T2DM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (90)

Trinity Clinical Research

Centreville, Alabama, 35042, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

San Fernando Valley Health Institute

Canoga Park, California, 91304, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Innovative Research of West Florida

Clearwater, Florida, 33756, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Adult Medicine of Lake County

Mt. Dora, Florida, 32757, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Evanston Premier Healthcare Research LLC

Skokie, Illinois, 60077, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Anderson Medical Research

Ft. Washington, Maryland, 20744, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Premier Research

Trenton, New Jersey, 08611, United States

Location

Medication Management

Greensboro, North Carolina, 27405, United States

Location

Meridian Clinical Research, LLC

Cincinnati, Ohio, 45219, United States

Location

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States

Location

Heritage Valley Multispecialty Group, Inc

Beaver, Pennsylvania, 15009, United States

Location

Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

Pittsburgh, Pennsylvania, 15236, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

HealthStar Physicians, P.C.

Morristown, Tennessee, 37813, United States

Location

Healthstar Physicians

Morristown, Tennessee, 37813, United States

Location

Elligo Clinical Research Center

Austin, Texas, 78738, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Medical Colleagues of Texas, LLP

Katy, Texas, 77450, United States

Location

Tapia Internal Medicine Clinic

Paris, Texas, 75462, United States

Location

Northeast Clinical Research of San Antonio

San Antonio, Texas, 78233, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Sugar Lakes Family Practice

Sugar Land, Texas, 77479, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Southwest Internal Medicine

St. George, Utah, 84790, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Medical Centre "Asklepiy"

Dupnitsa, Kyustendil, 2600, Bulgaria

Location

MHAT Botevgrad

Botevgrad, Sofia, 2140, Bulgaria

Location

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa), 1431, Bulgaria

Location

Medical Center Zdrave 1

Kozloduy, Vratsa, 3320, Bulgaria

Location

"Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD

Stara Zagora, 6000, Bulgaria

Location

Dr. M.B. Jones Inc.

Victoria, British Columbia, V8V 4A1, Canada

Location

G A Research Associates

Moncton, New Brunswick, E1G 1A7, Canada

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

Dawson Clinical Research

Guelph, Ontario, N1H 1B1, Canada

Location

Milestone Research Inc.

London, Ontario, N5W 6A2, Canada

Location

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, N7T 4X3, Canada

Location

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, M4G 3E8, Canada

Location

Manna Research Mirabel

Mirabel, Quebec, J7J 2K8, Canada

Location

Diex Recherche Victoriavile Inc.

Victoriaville, Quebec, G6P 6P6, Canada

Location

Diex Recherche Quebec Inc.

Québec, G1V 4T3, Canada

Location

Centre de Recherche Saint-Louis

Québec, G1W 4R4, Canada

Location

MUDr. Alena Vachova

České Budějovice, Jihočeský kraj, 37011, Czechia

Location

EDUMED s.r.o.

Broumov, Kralovehradecky KRAY, 550 01, Czechia

Location

Kardiologicka a Angiologicka Ambulance

Ostrava, Ostrava Město, 700 30, Czechia

Location

Clinical Trials Service s.r.o.

Uherské Hradiště, Zlín, 686 01, Czechia

Location

Agentura Science Pro

Olomouc, 779 00, Czechia

Location

Private Practice - Dr. Tomáš Brychta

Olomouc, 779 00, Czechia

Location

EUC Klinika Praha

Prague, 150 00, Czechia

Location

Clinical Trials Service s.r.o.

Uherské Hradiště, Czechia

Location

Belinus Orvosi és Számitástechnikai Bt

Debrecen, Hajdú-Bihar, 4025, Hungary

Location

Borbánya Praxis

Nyíregyháza, Borbánya, Szabolcs-Szatmár-Bereg, 4405, Hungary

Location

CLINFAN Szolgáltató Kft

Szekszárd, Tolna County, 7100, Hungary

Location

DRC Gyógyszervizsgáló Központ

Balatonfüred, Veszprém megye, 8230, Hungary

Location

ClinDiab Kft.

Budapest, 1089, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 04032, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Nakakinen clinic

Naka, Ibaraki, 311-0113, Japan

Location

Yokohama Minoru Clinic

Yokohama, Kanagawa, 232-0064, Japan

Location

Shiraiwa Medical Clinic

Kashihara, Osaka, 582-0005, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Seiwa Clinic

Adachi-ku, Tokyo, 120-0011, Japan

Location

Seiwa Clinic

Adachi-ku, Tokyo, 123-0845, Japan

Location

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0028, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Yokohama Minoru Clinic

Yokohama, 232-0064, Japan

Location

Oświęcimskie Centrum Badań Klinicznych

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

KO-MED Centra Kliniczne Pulawy

Puławy, Lublin Voivodeship, 24-100, Poland

Location

Zdrowie Osteo-Medic

Bialystok, Podlaskie Voivodeship, 15-351, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

Ruda Śląska, Silesian Voivodeship, 41-709, Poland

Location

Gabinet Lekarski Małgorzata Jadwiga Saryusz-Wolska

Lodz, 90-132, Poland

Location

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, 60-589, Poland

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

GCM Medical Group, PSC - Hato Rey Site

San Juan, 00917, Puerto Rico

Location

Related Publications (1)

• Amin NB, Frederich R, Tsamandouras N, Haggag AZ, Schuster T, Zmuda W, Palmer A, Vasas S, Buckley G, Smith TR, DuBrava SJ, Zhu Q, Johnson M. Evaluation of an oral small-molecule glucagon-like peptide-1 receptor agonist, lotiglipron, for type 2 diabetes and obesity: A dose-ranging, phase 2, randomized, placebo-controlled study. Diabetes Obes Metab. 2025 Jan;27(1):215-227. doi: 10.1111/dom.16005. Epub 2024 Oct 16.

  PMID: 39415344 DERIVED

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1 participant in placebo (T2DM) arm with withdrawal reason as Death in treatment phase was also counted in follow-up with the reason for discontinuation as death since exact date of last dose was unknown.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: October 27, 2022
• Primary Completion: July 14, 2023
• Study Completion: September 22, 2023
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (39); CA (11); JP (11); BU (5); HU (7); PL (7); CZ (8); PR (2)