What side effects are associated with this type of intervention?

Common treatments for diabetes, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide) and SGLT2 inhibitors (e.g., dapagliflozin, tofogliflozin), have specific side effects. GLP-1 receptor agonists often cause gastrointestinal symptoms like nausea and vomiting, and there are concerns about pancreatitis and potential pancreatic cancer. SGLT2 inhibitors can lead to urinary tract infections, genital infections, and in some cases, increased risk of amputations and fractures. Both classes of drugs are effective in improving glycemic control and promoting weight loss but require monitoring for these adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of type 2 diabetes that focus on blood sugar control and weight management. Notable among these are GLP-1 receptor agonists like liraglutide (approved for children ≥10 years) and extended-release exenatide, which improve glycemic control and can aid in weight loss. Dulaglutide is another GLP-1 receptor agonist approved for pediatric use. Additionally, SGLT2 inhibitors like dapagliflozin have been approved for adolescents and young adults, offering benefits in glycemic control and weight management. These drugs share similarities with the investigational drug PF-07081532, which is being studied for its effects on weight loss and blood sugar control.

What other types of research exist?

Promising novel alternatives to PF-07081532 for diabetes patients include: 1) Taspoglutide, a GLP-1 agonist, which has shown potential in glycemic control. 2) SKL-18287, a GLP-1 analog, also aimed at improving blood sugar levels. 3) DSP-7238, a DPP-IV inhibitor, which has demonstrated improvements in glycemic control and beta-cell protection in diabetic mice. 4) SGLT2 inhibitors like canagliflozin, empagliflozin, and dapagliflozin, which have shown benefits in glycemic control and cardiovascular outcomes.

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PF-07081532 + Rybelsus for Type 2 Diabetes and PF-07081532 for Obesity

Verified Trial

Phase 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you been diagnosed with Type 2 Diabetes?

Are you 18-75 years old?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline [(baseline is defined as the result closest prior to dosing at visit 3 (day 1)], week 12, 24

Summary

This trial is testing a new drug called PF-07081532 to see if it can help people lose weight or control their blood sugar. The study includes obese individuals without diabetes and diabetic patients already taking metformin. Participants will receive either the new drug or an approved treatment and will be monitored over time.

Who is the study for?

This trial is for adults aged 18-75 with Type 2 Diabetes on metformin or those with obesity without diabetes. Diabetics should have HgbA1c levels between 7.0% - 10.0%. People not adequately controlled by Metformin, or with certain BMI and fasting plasma glucose (FPG) levels are excluded.

What is being tested?

The study tests PF-07081532's safety and effectiveness in weight loss for obese individuals and blood sugar control for diabetics. Participants will receive either the active drug, a placebo, or Rybelsus if diabetic, over a period of up to 48 weeks with regular check-ins.

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions to diabetes medications such as digestive discomfort, low blood sugar episodes, potential allergic reactions, and other medication-specific effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Have you been told by a doctor that you have Type 2 Diabetes?

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Are you between 18 and 75 years old?

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Is your HgbA1c level between 7.0% and 10.0%?

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Are you only taking Metformin for your Type 2 Diabetes right now?

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline [(baseline is defined as the result closest prior to dosing at visit 3 (day 1)], week 12, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline [(baseline is defined as the result closest prior to dosing at visit 3 (day 1)], week 12, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline [(baseline is defined as the result closest prior to dosing at visit 3 (day 1)], week 12, 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)

Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)

Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)

+18 more

Other study objectives

Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)

Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)

Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)

+5 more

Side effects data

From 2021 Phase 1 trial • 66 Patients • NCT04305587

14%

Vaccination complication

14%

Dyspepsia

14%

Diarrhoea

14%

Decreased appetite

14%

Dermatitis contact

100%

80%

60%

40%

20%

Study treatment Arm

PF-07081532 10 mg Part A

Placebo Part A

PF-07081532 30 mg Part A

PF-07081532 60 mg Part A

PF-07081532 120 mg Part A

Placebo Part B

PF-07081532 180 mg Part B

Placebo Part C

PF-07081532 180 mg Part C

Trial Design

13Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: PF-07081532 80 mg T2DMExperimental Treatment1 Intervention

PF-07081532 80 mg daily in T2DM

Group II: PF-07081532 80 mg ObesityExperimental Treatment1 Intervention

PF-07081532 80 mg daily in Obesity

Group III: PF-07081532 40 mg T2DMExperimental Treatment1 Intervention

PF-07081532 40 mg daily in T2DM

Group IV: PF-07081532 260 mg T2DMExperimental Treatment1 Intervention

PF-07081532 260 mg daily in T2DM

Group V: PF-07081532 260 mg ObesityExperimental Treatment1 Intervention

PF-07081532 260 mg daily in Obesity

Group VI: PF-07081532 200 mg Obesity (Option 2)Experimental Treatment1 Intervention

PF-07081532 200 mg daily in Obesity

Group VII: PF-07081532 200 mg Obesity (Option 1)Experimental Treatment1 Intervention

PF-07081532 200 mg daily in Obesity

Group VIII: PF-07081532 20 mg T2DMExperimental Treatment1 Intervention

PF-07081532 20 mg daily in T2DM

Group IX: PF-07081532 160 mg T2DMExperimental Treatment1 Intervention

PF-07081532 160 mg daily in T2DM

Group X: PF-07081532 140 mg ObesityExperimental Treatment1 Intervention

PF-07081532 140 mg daily in Obesity

Group XI: Rybelsus 14 mg T2DMActive Control1 Intervention

Semaglutide 14 mg daily in T2DM

Group XII: Placebo T2DMPlacebo Group1 Intervention

Placebo daily in T2DM

Group XIII: Placebo ObesityPlacebo Group1 Intervention

Placebo in Obesity

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-07081532

2022

Completed Phase 1

~170

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes include GLP-1 receptor agonists, metformin, and SGLT2 inhibitors. GLP-1 receptor agonists, such as semaglutide, enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps lower blood sugar levels and promote weight loss. Metformin primarily reduces hepatic glucose production and improves insulin sensitivity, making it a first-line treatment. SGLT2 inhibitors work by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion in urine. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate therapy based on individual needs and treatment goals.

Assessing the quality of the evidence underlying recommendations in type 2 diabetes' commonly used clinical practice guidelines.Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.A patient-centered approach to managing patients with type 2 diabetes.