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OverweightPhase 1NCT06039826

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

A Phase 1 study testing LY3437943, Ethinyl Estradiol and Drospirenone in people with Overweight, run by Eli Lilly and Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Overweight
What is being tested?
LY3437943, Ethinyl Estradiol and Drospirenone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesUnited States
Study dates
12 Sep 2023to 11 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Postmenopausal female participants
  • Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)

Who cannot join

  • Have an unstable disease or a disease constituting a risk when taking the study intervention.
  • Have significant renal insufficiency
  • Have an important gastro-esophageal reflux disease, pyloric stenosis, gastroparesis or a history of gastric bypass surgery.
  • Have a history or presence of chronic or idiopathic acute pancreatitis.
  • Have a history of severe clinically significant multiple or severe drug allergies.
  • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Show all 18Show fewer
  • Have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix that have been resected with no evidence of metastatic disease for 3 years
  • Have any form of diabetes mellitus other than type 2
  • Have type 2 diabetes with HbA1c greater than or equal to 10% at screening
  • Have received an oral or transdermal patch hormone replacement therapy (HRT) within the last 1 month prior to screening or depot injectable HRT within the last 6 months
  • Have received any investigational drug within the last month or 5 half-lives of this drug, whichever is longer, prior to screening. If the half-life of the previous investigational drug is unknown, the washout period should be at least 3 months before screening
  • Show evidence of HIV infection or positive HIV antibodies
  • Have evidence of, or test positive for, anti-hepatitis C virus antibody unless a confirmatory test for hepatitis C virus RNA is negative
  • Test positive for hepatitis B surface antigen. In case a hepatitis B virus DNA test was also performed recently and is positive, the participant should be excluded independently of the hepatitis B surface antigen test result. The hepatitis B core antibody test is not used to assess eligibility
  • Have acute or chronic hepatitis, or signs and symptoms of any other liver disease, or with significant abnormalities in laboratory liver tests
  • Have a fasting triglyceride level greater than 500 mg/dL at screening
  • Used any nicotine product including tobacco or nicotine replacement products within 1 month prior to screening or a positive cotinine test at screening. Are unable or unwilling to refrain from using such products during the study
  • Have donated at least 450 mL of blood within 8 weeks before screening or intend to donate blood during the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • ICON Early Phase Services

    San Antonio, Texas, 78209

  • Qps-Mra, Llc

    South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1 Study to Investigate the Effect of LY3437943 on the Pharmacokinetics of the Combined Oral Contraceptive Ethinyl Estradiol and Drospirenone in Female Participants

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese. The safety and tolerability of LY3437943 when administered with COC will also be evaluated. This study will last up to approximately 29 weeks for each participant.

Conditions
Overweight
Being tested
LY3437943, Ethinyl Estradiol, Drospirenone
Keywords
Pharmacokinetics, Obesity, Oral Contraceptive
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3437943Drug

    Administered SC.

  • Ethinyl EstradiolDrug

    Administered orally

  • DrospirenoneDrug

    Administered orally

Study groups in NCT06039826
Study groupRoleWhat they receive
LY3437943 + Combined Oral Contraceptive (COC)ExperimentalThe COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
Receives: Drug: LY3437943; Drug: Ethinyl Estradiol; Drug: Drospirenone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol

    PK: AUC0-24 of Ethinyl Estradiol

    Measured: Predose on Day 1 up to 144 days postdose

  2. PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol

    PK: Cmax of Ethinyl Estradiol

    Measured: Predose on Day 1 up to 144 days postdose

  3. PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol

    PK: Tmax of Ethinyl Estradiol

    Measured: Predose on Day 1 up to 144 days postdose

  4. PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone

    PK: AUC0-24 of Drospirenone

    Measured: Predose on Day 1 up to 144 days postdose

  5. PK: Maximum Observed Concentration (Cmax) of Drospirenone

    PK: Cmax of Drospirenone

    Measured: Predose on Day 1 up to 144 days postdose

  6. PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone

    PK: Tmax of Drospirenone

    Measured: Predose on Day 1 up to 144 days postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start12 Sep 2023
  3. Primary completion11 Jul 2024
  4. Study completion11 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06039826
Sponsor's protocol ID
18533
Other IDs
J1I-MC-GZBV
Status last verified
Jul 2024
First submitted
11 Sep 2023
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3437943, Ethinyl Estradiol and Drospirenone in people with Overweight, run by Eli Lilly and Company at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol (time frame: Predose on Day 1 up to 144 days postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06039826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.

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