PF-08653945 + PF-08653944 for Obesity

(SOLIS-1 Trial)

Not currently recruiting at 65 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of two new drugs, PF-08653945 and PF-08653944, for weight loss, either alone or combined, compared to a placebo. It targets adults with obesity or those overweight with related health issues such as high blood pressure, high cholesterol, heart disease, or sleep apnea. Participants are divided into groups, with some receiving the drugs and others a placebo, to evaluate the treatments' effectiveness. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that both PF-08653945 and PF-08653944 have been studied for their safety in treating obesity. Earlier studies examined PF-08653945 as a long-lasting injection for weight loss. Although detailed safety information for PF-08653945 isn't widely available, ongoing research focuses on understanding its safety.

PF-08653944 shares a safety profile with other drugs in its class, known as GLP-1 receptor agonists, which are generally well-tolerated. Most reported side effects were mild to moderate, primarily affecting the stomach, such as nausea or diarrhea.

Researchers are also studying the safety of using PF-08653945 and PF-08653944 together. So far, studies have not found any unexpected safety issues with this combination.

As the trial progresses, more detailed safety information is being collected. However, current evidence suggests that these treatments are generally well-tolerated.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08653945 and PF-08653944 because these treatments offer a fresh approach to tackling obesity. Unlike current options such as appetite suppressants or drugs that inhibit fat absorption, PF-08653945 and PF-08653944 are designed to work through novel mechanisms. These treatments are administered via subcutaneous injections, potentially allowing for more direct and efficient delivery. This innovative approach could lead to improved outcomes for patients struggling with obesity, making these treatments a promising new frontier in weight management.

What evidence suggests that this trial's treatments could be effective for obesity?

Studies have shown that PF-08653944 aids weight loss, with monthly doses leading to reductions potentially up to 12.3% more than a placebo in trials. In this trial, participants in different cohorts will receive either PF-08653945 alone, PF-08653944 alone, or a combination of both, while some will receive a placebo for comparison. The effects may be even stronger when combined with PF-08653945. These treatments mimic hormones that reduce hunger and help control blood sugar levels. Early results suggest this combination could be a promising option for weight loss in people with obesity. The data appears promising, but further research is needed to confirm these findings.12346

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are obese (BMI 30–50) or overweight (BMI 27–29.9) with at least one weight-related health issue like high blood pressure, abnormal cholesterol, heart disease, or sleep apnea.

Inclusion Criteria

I am 18 years old or older.
My BMI is between 30 and 50.
I am overweight and have a related health condition like high blood pressure or sleep apnea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of PF-08653945, PF-08653944, or placebo for weight loss

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08653944
  • PF-08653945

Trial Overview

The study tests two new drugs, PF-08653944 and PF-08653945—alone and together—for weight loss compared to a placebo. Participants are randomly assigned to different groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment3 Interventions
Group II: Cohort 2Experimental Treatment3 Interventions
Group III: Cohort 1Experimental Treatment2 Interventions

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Pfizer's Ultra-Long-Acting Injectable GLP-1 RA Shows ...

Pfizer's Ultra-Long-Acting Injectable GLP-1 RA Shows Robust and Continued Weight Loss with Monthly Dosing in Phase 2b Trial · About PF-08653944 ( ...

A Study of PF-08653945 and PF-08653944 in Adults With ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...

Pfizer Phase IIb Data Support Monthly GLP-1 Dosing for ...

VESPER-3 trial demonstrated significant placebo-adjusted weight loss with monthly dosing of PF-08653944, supporting its potential as a viable ...

New Monthly GLP-1 Data Shows Potential in Obesity ...

Pfizer's PF-08653944 achieved significant weight loss with monthly dosing, reducing dosing frequency while maintaining efficacy in the VESPER-3 ...

A Study to Learn About the Study Medicine (PF-08653944) ...

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D). ClinicalTrials.gov ID NCT07400653.

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These data show robust and continuous weight loss after switching to monthly dosing, with no plateau observed at week 28, suggesting continued ...