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
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| ClinicalTrials.gov Identifier: NCT05579977 |
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Recruitment Status :
Terminated
(The decision to terminate clinical development of PF-07081532 is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.)
First Posted : October 14, 2022
Last Update Posted : February 20, 2024
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus Obesity | Drug: PF-07081532 Other: Placebo Drug: Rybelsus | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 902 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 27, 2022 |
| Actual Primary Completion Date : | July 14, 2023 |
| Actual Study Completion Date : | September 22, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
Drug Information
available for:
Semaglutide
| Arm | Intervention/treatment |
|---|---|
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Experimental: PF-07081532 20 mg T2DM
PF-07081532 20 mg daily in T2DM
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 40 mg T2DM
PF-07081532 40 mg daily in T2DM
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 80 mg T2DM
PF-07081532 80 mg daily in T2DM
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 160 mg T2DM
PF-07081532 160 mg daily in T2DM
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 260 mg T2DM
PF-07081532 260 mg daily in T2DM
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Placebo Comparator: Placebo T2DM
Placebo daily in T2DM
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Other: Placebo
No drug |
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Experimental: PF-07081532 80 mg Obesity
PF-07081532 80 mg daily in Obesity
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 140 mg Obesity
PF-07081532 140 mg daily in Obesity
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 200 mg Obesity (Option 1)
PF-07081532 200 mg daily in Obesity
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 200 mg Obesity (Option 2)
PF-07081532 200 mg daily in Obesity
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Experimental: PF-07081532 260 mg Obesity
PF-07081532 260 mg daily in Obesity
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Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist |
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Active Comparator: Rybelsus 14 mg T2DM
Semaglutide 14 mg daily in T2DM
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Drug: Rybelsus
Oral Semaglutide |
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Placebo Comparator: Placebo Obesity
Placebo in Obesity
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Other: Placebo
No drug |
Primary Outcome Measures :
- Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM) [ Time Frame: baseline, week 32 ]
- Placebo-adjusted, percent change from baseline in body weight at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
Secondary Outcome Measures :
- Proportion of participants who achieve HbA1C <7% (<53 mmol/mol) at Week 32 in T2DM [ Time Frame: week 32 ]
- Placebo-adjusted, change from baseline in FPG at Week 32 in T2DM [ Time Frame: baseline, week 32 ]
- Placebo-adjusted, percent change from baseline in body weight at Week 32 in T2DM [ Time Frame: baseline, week 32 ]
- Placebo-adjusted, change from baseline in HbA1C at Week 32 with Rybelsus in T2DM [ Time Frame: baseline, week 32 ]
- Proportion of participants achieving ≥5% body weight loss at Week 32 relative to baseline in Obesity [ Time Frame: baseline, week 32 ]
- Proportion of participants achieving ≥10% body weight loss at Week 32 relative to baseline in Obesity [ Time Frame: Week 32 ]
- Proportion of participants achieving≥15% body weight loss at Week 32 relative to baseline in Obesity [ Time Frame: Week 32 ]
- Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
- Placebo-adjusted, absolute change from baseline in waist-to hip ratio at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
- Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Resistance at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
- Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Sensitivity at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
- To compare PF 07081532 to placebo in the number of participants reporting Adverse Events [ Time Frame: week 36 and 48 ]
- To compare PF 07081532 to placebo in the number of participants reporting Serious Adverse Events [ Time Frame: week 36, week 48 ]
- To compare PF 07081532 to placebo in the number of participants reporting Adverse Events leading to discontinuation [ Time Frame: week 36, week 48 ]
- To compare PF 07081532 to placebo in the number of participants reporting Hypoglycemia [ Time Frame: Week 36, week 48 ]
- To compare PF 07081532 to placebo in the number of participants with clinical laboratory abnormalities [ Time Frame: Week 36, week 48 ]
- To compare PF 07081532 to placebo in the number of participants with vital sign abnormalities [ Time Frame: Week 36, Week 48 ]
- To compare PF 07081532 to placebo in the number of participants with ECG abnormalities [ Time Frame: Week 34, week 46 ]
- Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity [ Time Frame: Week 32 and 44 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05579977
Locations
Show 90 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05579977 |
| Other Study ID Numbers: |
C3991004 2022-002834-15 ( EudraCT Number ) |
| First Posted: | October 14, 2022 Key Record Dates |
| Last Update Posted: | February 20, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pfizer:
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Diabetes Mellitus Obesity |
Additional relevant MeSH terms:
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Diabetes Mellitus Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overweight Overnutrition |
Nutrition Disorders Body Weight Semaglutide Glucagon-Like Peptide-1 Receptor Agonists Hypoglycemic Agents Physiological Effects of Drugs |