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Danuglipron for Obesity

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Pfizer

Disqualifiers: Significant medical conditions, Drug absorption issues, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese: * how the study medicine, danuglipron, is taken up into the blood * if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin) * about the safety and tolerability of danuglipron The study will take place in 4 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have any conditions affecting drug absorption or known allergies to certain drugs used in the study.

What makes the drug Danuglipron unique for treating obesity?

Danuglipron is a novel treatment for obesity that may offer a different mechanism of action compared to existing drugs, although specific details about its uniqueness are not provided in the available research.¹ ² ³ ⁴ ⁵

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for healthy adults aged 18 to less than 65 who are overweight or obese, with a BMI of ≥25.0-45.4 kg/m2 and weigh more than 110 pounds. It's not specified who can't join the trial.

Inclusion Criteria

My BMI is between 25.0 and 45.4, and I weigh more than 110 lbs.

I am between 18 and 64 years old.

Exclusion Criteria

I am allergic to GLP-1R agonists or certain cholesterol medications.

I have no significant medical conditions or abnormal lab results.

I have a condition that might affect how drugs are absorbed in my body.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple oral doses of danuglipron with and without atorvastatin or rosuvastatin

20-23 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Danuglipron (Other)

Trial OverviewThe study investigates how danuglipron is absorbed into the blood after multiple doses in overweight/obese individuals and if it affects how the body processes statins like Atorvastatin and Rosuvastatin over approximately 5.5 to 6 months.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment2 Interventions

Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin

Group II: Cohort 3Experimental Treatment2 Interventions

Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin

Group III: Cohort 2Experimental Treatment2 Interventions

Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin

Group IV: Cohort 1Experimental Treatment2 Interventions

Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin

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Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Findings from Research

The metabolite (+)-norfenfluramine, derived from the weight-loss drug (+)-fenfluramine, can cause significant contraction of arterial smooth muscle through activation of 5-HT(2A) receptors, indicating a mechanism for its vasoactive properties.

In conscious rats, (+)-norfenfluramine led to a dose-dependent increase in mean arterial blood pressure, which was largely blocked by the 5-HT(2A) receptor antagonist ketanserin, highlighting its potential to raise blood pressure and suggesting caution in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fenfluramine metabolite (+)-norfenfluramine is vasoactive.Ni, W., Li, MW., Thakali, K., et al.[2017]

In a study involving 44 subjects with varying degrees of obesity, desopimon demonstrated a strong appetite-inhibiting effect in 41 patients, leading to an average weight loss of 12.9 kg over six weeks, primarily from fat reduction.

The treatment was well-tolerated with minimal side effects, and it showed beneficial changes in serum triglycerides and free fatty acids, suggesting its potential as an effective adjunct therapy for hyperphagic obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Desopimon in the treatment of obesity].Balabanski, L., Tashev, T., Meretev, A., et al.[2013]

Several anti-obesity drugs are in clinical development, including centrally-acting drugs like radafaxine and rimonabant, which has completed phase III trials, indicating it is the most advanced in testing.

Other drug categories being explored target satiety signals and fat absorption, such as glucagon-like peptide-1 drugs (like liraglutide) and lipase inhibitors (like cetilistat), showing a diverse approach to obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity drugs in clinical development.Halford, JC.[2022]