Danuglipron for Obesity

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Significant medical conditions, Drug absorption issues, GLP-1R intolerance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 11-13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how the new medicine, danuglipron, is absorbed into the blood and its safety when taken over several days. It targets individuals who are overweight or obese to understand how their bodies process the drug. Participants will take danuglipron for about four months. Those with a BMI of 25 or higher and weighing more than 110 pounds may qualify, unless they have other serious health issues or difficulties with similar medications. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Do I need to stop 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 danuglipron is likely to be safe for humans?

Research has shown that danuglipron has been tested for safety in people with obesity. In these studies, the drug caused significant weight loss, though some participants stopped taking it due to side effects. The safety profile—how the drug acts in the body—aligned with expectations for this type of treatment.

The current trial, in its early stages, focuses on understanding how the drug is absorbed and tolerated in the body. This phase aims to determine the safest way to use it in humans. If danuglipron receives approval for other uses in the future, it will have undergone additional tests for safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for obesity focus on appetite suppression or fat absorption, but danuglipron works differently by targeting the mechanisms that regulate glucose and insulin levels, which can also impact weight. This approach might offer a new way to manage obesity, potentially offering benefits beyond weight loss, like improved metabolic health. Researchers are excited because danuglipron could provide a more comprehensive solution by not only helping with weight reduction but also addressing underlying metabolic issues associated with obesity.

What evidence suggests that danuglipron might be an effective treatment for obesity?

Research has shown that danuglipron can help adults who are overweight or obese lose weight. In earlier studies, participants taking danuglipron lost between 5% and 13% of their body weight over six to eight months, compared to those who took a placebo (a pill with no active ingredients). These results were significant, indicating the weight loss was not by chance. The treatment was also safe in these studies, suggesting that danuglipron could be a good option for those wanting to lose weight. ^{1 2 3 6 7}

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 who are generally healthy but have overweight or obesity issues. Participants will be involved in the study for approximately 15 weeks, which is about 4 months.

Inclusion Criteria

Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion Criteria

I have no significant medical conditions or abnormal lab results.

Known intolerance/hypersensitivity to a GLP-1R agonist

I have a condition that might affect how my body absorbs medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of danuglipron to evaluate pharmacokinetics, safety, and tolerability

11-13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Danuglipron

Trial Overview The study focuses on understanding how danuglipron, a medication under investigation, behaves in the bloodstream after multiple doses over several days and assessing its safety and tolerability in participants.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Participants will receive multiple doses of danuglipron

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

Citations

1. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-announces-topline-phase-2b-results-oral-glp-1r

Pfizer Announces Topline Phase 2b Results of Oral GLP ... Danuglipron demonstrated mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks While ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40539310/

Efficacy and safety of danuglipron (PF-06882961) in adults ... Danuglipron resulted in statistically significant and clinically meaningful reductions in body weight versus placebo over 26 or 32 weeks.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/eli-lilly-orforglipron-first-phase-iii-win/

Eli Lilly's shares up as oral GLP-1RA scores in first Phase ... Eli Lilly's Phase III trial with its oral weight loss pill, orforglipron, has met its primary endpoint, reducing A1C levels by up to 1.6%.

4. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-advances-development-once-daily-formulation-oral-glp

Pfizer Advances Development of Once-Daily Formulation ... The most advanced of them, danuglipron, has demonstrated good efficacy ... “Following a thorough analysis of our previous Phase 2b data and trial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12326921/

Efficacy and safety of danuglipron (PF‐06882961) in adults ... Overall, the outcomes of this Phase 2b study demonstrate the efficacy of danuglipron at target doses of 40–200 mg BID in participants with obesity, relative to ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/features/obesity-trials-to-watch/

Obesity: Six trials to watch over the next 12 months The trial is evaluating the efficacy and safety of the drug in adults with obesity. Danuglipron tromethamine is another pipeline drug that ...

7. semanticscholar.org semanticscholar.org/paper/Efficacy-and-safety-of-danuglipron-%28PF%E2%80%9006882961%29-in-Buckeridge-Cobain/c45186e8582e67af976ecc9696cd8bce674cf99e

Efficacy and safety of danuglipron (PF‐06882961) in adults ... The overall safety profile observed in this study was consistent with expectations for the mechanism, although discontinuation rates due to AEs were higher ...