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

Recruiting at 88 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must be taking: Metformin

Must not be taking: Weight loss drugs

Disqualifiers: Gallbladder disease, Pancreatitis, Type 1 diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 36-48 weeks

780 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

If you have diabetes and are taking metformin, you can continue using it during the trial. However, if you are using any other diabetes medications or weight loss drugs, you will need to stop them to participate.

What data supports the effectiveness of the drug PF-07081532 + Rybelsus for Type 2 Diabetes and PF-07081532 for Obesity?

Rybelsus, which contains semaglutide, has been shown to improve blood sugar control and reduce body weight in people with type 2 diabetes, as demonstrated in the PIONEER clinical trials. It is effective in providing better glycemic control compared to other common diabetes medications and is associated with weight loss. ^{1 2 3 4 5}

Is the combination of PF-07081532 and Rybelsus safe for humans?

Rybelsus (oral semaglutide) has been shown to be safe in large clinical trials for people with type 2 diabetes, with a safety profile similar to other drugs in its class. It is generally well-tolerated, with no major safety concerns, and has been found to be safe for people with high cardiovascular risk and impaired kidney function. ^{1 2 3 5 6}

What makes the drug PF-07081532 + Rybelsus unique for treating type 2 diabetes and obesity?

The drug combination of PF-07081532 and Rybelsus is unique because Rybelsus is the first oral form of a GLP-1 receptor agonist, which traditionally was only available as an injection. This oral form, combined with PF-07081532, offers a novel approach to managing type 2 diabetes and obesity by improving blood sugar control and promoting weight loss without the need for injections. ^{1 2 3 5 7}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

Inclusion Criteria

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

Is your HgbA1c level between 7.0% and 10.0%?

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

Exclusion Criteria

Your fasting blood sugar level is below 126 mg/dL (7 mmol/L).

You have a body mass index (BMI) of 23.0 kg/m2 (20.0 kg/m2 in Japan) or higher.

You have type 2 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active study drug, placebo, or Rybelsus for diabetes, or active study drug or placebo for obesity

36-48 weeks

Visits every 4 weeks with phone calls in between

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PF-07081532
• Placebo
• Rybelsus

Trial Overview 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.

Participant Groups

Group I: PF-07081532 80 mg T2DM Experimental Treatment 1 Intervention

PF-07081532 80 mg daily in T2DM

Group II: PF-07081532 80 mg Obesity Experimental Treatment 1 Intervention

PF-07081532 80 mg daily in Obesity

Group III: PF-07081532 40 mg T2DM Experimental Treatment 1 Intervention

PF-07081532 40 mg daily in T2DM

Group IV: PF-07081532 260 mg T2DM Experimental Treatment 1 Intervention

PF-07081532 260 mg daily in T2DM

Group V: PF-07081532 260 mg Obesity Experimental Treatment 1 Intervention

PF-07081532 260 mg daily in Obesity

Group VI: PF-07081532 200 mg Obesity (Option 2) Experimental Treatment 1 Intervention

PF-07081532 200 mg daily in Obesity

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

PF-07081532 200 mg daily in Obesity

Group VIII: PF-07081532 20 mg T2DM Experimental Treatment 1 Intervention

PF-07081532 20 mg daily in T2DM

Group IX: PF-07081532 160 mg T2DM Experimental Treatment 1 Intervention

PF-07081532 160 mg daily in T2DM

Group X: PF-07081532 140 mg Obesity Experimental Treatment 1 Intervention

PF-07081532 140 mg daily in Obesity

Group XI: Rybelsus 14 mg T2DM Active Control 1 Intervention

Semaglutide 14 mg daily in T2DM

Group XII: Placebo T2DM Placebo Group 1 Intervention

Placebo daily in T2DM

Group XIII: Placebo Obesity Placebo Group 1 Intervention

Placebo in Obesity

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

Semaglutide, a GLP-1 receptor agonist with a long half-life, effectively promotes insulin secretion in a glucose-dependent manner, making it a valuable treatment for type 2 diabetes, approved for use worldwide and in Japan since 2018.

Oral semaglutide (Rybelsus®) is the first GLP-1 receptor agonist available in pill form, showing continuous benefits in glycemic control for patients with type 2 diabetes across various stages, as demonstrated in multiple global clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist]. Miyasaka, K.[2022]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Oral semaglutide significantly reduces HbA1c levels and body weight in patients with type 2 diabetes, showing greater efficacy than placebo and other antidiabetic agents in a review of 11 randomized controlled trials involving 9890 patients.

While oral semaglutide is effective in managing blood glucose and weight, it is associated with increased gastrointestinal side effects like nausea and vomiting, although it has a favorable safety profile regarding severe hypoglycemia and cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral semaglutide for type 2 diabetes: A systematic review and meta-analysis. Avgerinos, I., Michailidis, T., Liakos, A., et al.[2021]

Oral semaglutide (Rybelsus®), a GLP-1 receptor agonist, not only helps lower blood sugar levels in people with type 2 diabetes but also promotes significant weight loss and has a lower risk of causing hypoglycemia.

Clinical studies indicate that GLP-1 receptor agonists are safe for individuals with type 2 diabetes and chronic kidney disease, and they may offer additional benefits such as protecting kidney function and reducing the risk of major cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes. Selvarajan, R., Subramanian, R.[2023]

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. Qin, W., Yang, J., Deng, C., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]

2. Japan pubmed.ncbi.nlm.nih.gov

[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist]. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Oral semaglutide for type 2 diabetes: A systematic review and meta-analysis. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Oral semaglutide in type 2 diabetes. [2021]