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

JRCT ID: jRCT2031220457

Registered date:25/11/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes Mellitus Obesity
• Date of first enrollment: 26/11/2022
• Target sample size: 780
• Countries of recruitment: US,Japan,Canada,Japan,Czechia,Japan,Hungary,Japan,Poland,Japan,Perto Rico,Japan
• Study type: Interventional

Intervention(s)

Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Other: Placebo
No drug
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: PF-07081532
Oral glucagon-like peptide-1 receptor agonist
Drug: Rybelsus
Oral Semaglutide
Other: Placebo
No drug

Outcome(s)

Primary Outcome

Primary Outcome Measures :
1.Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM) [ Time Frame: baseline, week 32 ]
2.Placebo-adjusted, percent change from baseline in body weight at Week 32 in Obesity [ Time Frame: baseline, week 32 ]

Secondary Outcome

Secondary Outcome Measures :
1.Proportion of participants who achieve HbA1C <7% (<53 mmol/mol) at Week 32 in T2DM [ Time Frame: week 32 ]
2.Placebo-adjusted, change from baseline in FPG at Week 32 in T2DM [ Time Frame: baseline, week 32 ]
3.Placebo-adjusted, percent change from baseline in body weight at Week 32 in T2DM [ Time Frame: baseline, week 32 ]
4.Placebo-adjusted, change from baseline in HbA1C at Week 32 with Rybelsus in T2DM [ Time Frame: baseline, week 32 ]
5.Proportion of participants achieving >=5% body weight loss at Week 32 relative to baseline in Obesity [ Time Frame: baseline, week 32 ]
6.Proportion of participants achieving >=10% body weight loss at Week 32 relative to baseline in Obesity [ Time Frame: Week 32 ]
7.Proportion of participants achieving>=15% body weight loss at Week 32 relative to baseline in Obesity [ Time Frame: Week 32 ]
8.Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
9.Placebo-adjusted, absolute change from baseline in waist-to hip ratio at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
10.Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Resistance at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
11.Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Sensitivity at Week 32 in Obesity [ Time Frame: baseline, week 32 ]
12.To compare PF 07081532 to placebo in the number of participants reporting Adverse Events [ Time Frame: week 36 and 48 ]
13.To compare PF 07081532 to placebo in the number of participants reporting Serious Adverse Events [ Time Frame: week 36, week 48 ]
14.To compare PF 07081532 to placebo in the number of participants reporting Adverse Events leading to discontinuation [ Time Frame: week 36, week 48 ]
15.To compare PF 07081532 to placebo in the number of participants reporting Hypoglycemia [ Time Frame: Week 36, week 48 ]
15.To compare PF 07081532 to placebo in the number of participants with clinical laboratory abnormalities [ Time Frame: Week 36, week 48 ]
17.To compare PF 07081532 to placebo in the number of participants with vital sign abnormalities [ Time Frame: Week 36, Week 48 ]
18.To compare PF 07081532 to placebo in the number of participants with ECG abnormalities [ Time Frame: Week 34, week 46 ]
19.Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity [ Time Frame: Week 32 and 44 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Inclusion Criteria:
T2DM
1.T2DM inadequately controlled with metformin
2.BMI >=23.0 kg/m2 (>=20.0 kg/m2 in Japan)
3.HbA1C of 7% to 10% (53-86 mmol/mol)
4.FPG <=270 mg/dL (15 mmol/L) Obesity
5.BMI >=30.0 kg/m2
6.HbA1C <=6.4% (47 mmol/mol)
7.FPG <=126 mg/dL (7 mmol/L)

Exclude criteria

Exclusion Criteria:
1.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)
2.Use of pharmacological agents with approved indication for weight loss
3.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;
4.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
5.Clinically significant cardiovascular conditions
6.Uncontrolled blood pressure
7.Personal or within first-degree relative family history of MTC or MEN2
8.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
9.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 Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05579977