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Obicetrapib with Oral Contraceptives in Healthy Women

Phase 1
Waitlist Available
Led By Kent A Swaine
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures
Be between 18 and 65 years old
Must not have
Male
History of Hypertension, or seated blood pressure for a minimum of 5 minutes >140mmHg systolic, or > 80 mmHg, diastolic at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon completion of treatment c (day -6) and treatments b+c (day 12)
Awards & highlights

Summary

This trial will investigate how Obicetrapib affects the levels of Drospirenone and Ethinyl Estradiol in the body of 30 healthy adult women.

Who is the study for?
This trial is for healthy, non-smoking women aged 18-35 who are suitable for hormonal contraception. Participants must have a BMI of 18.5-29.9 and agree to stop any current hormonal contraceptives, avoiding pregnancy by abstaining from sex or using non-hormonal birth control methods.
What is being tested?
The study tests how Obicetrapib affects the body's handling of a combined oral contraceptive (COC) containing Drospirenone and Ethinyl Estradiol in 30 adult female volunteers. It compares the levels of COC with and without Obicetrapib.
What are the potential side effects?
Potential side effects may include those commonly associated with oral contraceptives such as nausea, headaches, mood changes, breast tenderness, weight gain, menstrual changes or potential new side effects from Obicetrapib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 18.5 and 29.9.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am male.
Select...
I have high blood pressure or my blood pressure is above 140/80.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of treatment c (day -6) and treatments b+c (day 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of treatment c (day -6) and treatments b+c (day 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib
Maximum observed plasma concentration (Cmax) of COC

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)Experimental Treatment1 Intervention
Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet
Group II: Treatment B: ObicetrapibExperimental Treatment1 Intervention
Obicetrapib 10 mg tablets (daily)
Group III: Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)Experimental Treatment2 Interventions
Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
2024
Completed Phase 3
~840
Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)
2024
Completed Phase 1
~30
Drospirenone / Ethinyl Estradiol (COC)
2024
Completed Phase 1
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

NovumIndustry Sponsor
1 Previous Clinical Trials
72 Total Patients Enrolled
NewAmsterdam PharmaLead Sponsor
16 Previous Clinical Trials
13,872 Total Patients Enrolled
Kent A SwainePrincipal InvestigatorNovum Pharmaceutical Research Services, Inc.
~19 spots leftby Sep 2025
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