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

Recruiting at 100 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new drug, PF-07081532, can safely aid weight loss in people with obesity and help those with type 2 diabetes (T2DM) manage blood sugar levels. For diabetes, participants will receive either the new drug, a placebo (a pill with no active medicine), or an existing diabetes medication called Rybelsus (semaglutide). For obesity, the trial will compare the new drug to a placebo. Suitable candidates for this study include individuals struggling with obesity who do not have diabetes, or those with type 2 diabetes who are managing their condition with only metformin. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-07081532, a daily pill tested for type 2 diabetes and obesity, appears safe. In studies where participants took various doses of PF-07081532, most did not experience serious side effects, indicating the treatment was generally well-tolerated. Its safety profile is similar to other treatments with the same mechanism.

In earlier tests, some participants experienced mild to moderate side effects, but these were manageable. For those considering joining a trial with PF-07081532, this suggests that researchers are closely monitoring the treatment for safety.

Rybelsus, the other treatment in the trial for type 2 diabetes, has already received FDA approval for blood sugar control. Common side effects include nausea, diarrhea, and stomach pain, but many tolerate it well.

Both treatments are under study to ensure they aid in weight loss for obesity and blood sugar control in diabetes while remaining safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07081532 for Type 2 Diabetes and Obesity because it introduces a potentially novel mechanism of action. Unlike standard treatments like metformin or insulin for diabetes, or lifestyle changes and medications like orlistat for obesity, PF-07081532 targets pathways that might offer more effective blood sugar control and weight loss. Additionally, its oral administration could be more convenient compared to injectable options, making it easier for patients to use regularly. This new approach could lead to improved outcomes for patients who struggle with current therapies.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes and Obesity?

Previous studies have shown that the investigational drug PF-07081532 holds promise for treating both type 2 diabetes and obesity. Research indicates that this drug, which mimics a natural hormone in the body, helps lower blood sugar levels and promote weight loss. Early data suggests it can effectively reduce HbA1c, a measure of long-term blood sugar control, in people with type 2 diabetes and support weight loss in those with obesity. In this trial, participants with type 2 diabetes may receive PF-07081532 at various dosages or Rybelsus, another treatment for type 2 diabetes. Studies have shown that Rybelsus can lower HbA1c more than some other diabetes medications. Both treatments improve the body's use of insulin, which is important for managing diabetes and aiding weight loss. ^{1 2 3 5 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38751362/

Once-daily oral small-molecule glucagon-like peptide-1 ... Aim: To investigate the effects of lotiglipron (PF-07081532), a once-daily, oral small-molecule glucagon-like peptide-1 receptor agonist, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39415344/

A dose-ranging, phase 2, randomized, placebo-controlled ... The aim was to investigate the effects of lotiglipron, a once-daily, oral small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist, in participants with ...

3. cdn.pfizer.com cdn.pfizer.com/pfizercom/clinical%20trials/csr%20synopsis/C3991002%20Public%20Disclosure%20Synopsis%20.pdf?ok90h43XlyYat789Mo0lUZ7_pcO1nTj8=

clinical study report synopsis This was a randomized, double-blind (investigator- and participant-blind), sponsor-open, placebo-controlled, multiple oral dose-escalating study of PF-07081532.

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16005

Evaluation of an oral small‐molecule glucagon‐like peptide‐1 ... The efficacy (HbA1c and/or body weight) of a range of lotiglipron doses was demonstrated in T2D and obesity cohorts. The safety profile was ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05579977?term=NCT05579977&rank=1

Trial to Learn About the Study Medicine (PF-07081532 ... 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 ...

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15643

Once‐daily oral small‐molecule glucagon‐like peptide‐1 ... To investigate the effects of lotiglipron (PF-07081532) ... obesity, indicated a safety and tolerability profile consistent with the mechanism of ...