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Hormone Therapy

LY3437943 for Obesity

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal female participants

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose on day 1 up to 144 days postdose

Awards & highlights

Study Summary

This trial will test if a new drug can affect the levels of a contraceptive in overweight/obese postmenopausal women, and assess its safety. Study will last ~29 weeks.

Who is the study for?

This trial is for postmenopausal women who are overweight or obese with a BMI of 27.0 to 40.0 kg/m². Participants should not have severe drug allergies, HIV, hepatitis C or other liver diseases, high fasting triglyceride levels, recent blood donations, unstable diseases that risk taking the study intervention, significant renal insufficiency, certain cancers within the past 5 years except specific skin carcinomas and in situ cervical carcinoma resected over three years ago without metastasis.Check my eligibility

What is being tested?

The trial tests LY3437943's effect on blood levels of oral contraceptives (ethinyl estradiol and drospirenone) in postmenopausal females who are overweight/obese when administered subcutaneously. It also assesses safety and tolerability when used together with these contraceptives over approximately 29 weeks.See study design

What are the potential side effects?

While specific side effects for LY3437943 aren't listed here, common side effects from similar treatments may include injection site reactions, hormonal imbalances like mood swings or irregular bleeding patterns if any residual menstrual cycle exists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman who has gone through menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose on day 1 up to 144 days postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose on day 1 up to 144 days postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 up to 144 days postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

PK: Maximum Observed Concentration (Cmax) of Drospirenone

PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: LY3437943 + Combined Oral Contraceptive (COC)Experimental Treatment3 Interventions

The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Drospirenone

2023

Completed Phase 1

~59530

LY3437943

2022

Completed Phase 2

~950

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,617 Previous Clinical Trials

3,201,153 Total Patients Enrolled

54 Trials studying Obesity

40,828 Patients Enrolled for Obesity

Study DirectorEli Lilly and Company

1,346 Previous Clinical Trials

405,347 Total Patients Enrolled

37 Trials studying Obesity

20,547 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being admitted to this medical trial?

"The lower limit for entry into this medical trial is 40 years of age, while the upper boundary lies at 60 years."

Answered by AI

Are researchers actively seeking participants for this experiment?

"Based on what we can find on clinicaltrials.gov, this particular medical study is not actively recruiting any more patients. It was first launched in September of 2023 and has been inactive ever since; however, 369 other trials are currently enrolling new participants."

Answered by AI

Do I satisfy the requirements to join this research project?

"To qualify for this trial, participants must be aging between 40 and 60 years old while displaying signs of obesity. Currently, 39 people are being considered for enrollment in the study."

Answered by AI

What safety considerations should be taken into account when using LY3437943 in conjunction with a Combined Oral Contraceptive (COC)?

"Taking into consideration the limited data available, our team at Power rated LY3437943 + Combined Oral Contraceptive (COC) a 1 on the safety scale due to its status as being in Phase 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039826.

All > Overweight