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HealthyPhase 1NCT05959096

A Study of LY3437943 in Healthy Participants With a High Body Mass Index

A Phase 1 study testing LY3437943 in people with Healthy, run by Eli Lilly and Company at 1 site 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 study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY3437943
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
18 Jul 2023to 25 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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
  • Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive
  • Are agreeable to receiving study treatment by injections under the skin or through a vein.

Who cannot join

  • Have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form)
  • Have a significant history of, or presence of, any of the following disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Have known allergies to LY3437943, related compounds, or any components of the formulation
  • Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day.
  • Is a known user of drugs of abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: Effect of Injection Site on the Relative Bioavailability of a Single Dose of LY3437943 in Healthy Participants With a High Body Mass Index

The study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A. In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 157 days and 99 days for Part A and Part B, respectively.

Conditions
Healthy
Being tested
LY3437943

What participants receive

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

  • LY3437943Drug

    Administered SC

  • LY3437943Drug

    Administered IV

Study groups in NCT05959096
Study groupRoleWhat they receive
LY3437943 (Part A)ExperimentalLY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen
Receives: Drug: LY3437943
LY3437943 (Part B)ExperimentalLY3437943 administered intravenously (IV)
Receives: Drug: LY3437943

What is being measured

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

  1. Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

    Part A: PK: AUC(0-∞) of LY3437943

    Measured: Predose on Day 1 up to 43 days postdose (Part A)

  2. Part A: PK: Maximum Concentration (Cmax) of LY3437943

    Part A: PK: Cmax of LY3437943

    Measured: Predose on Day 1 up to 43 days postdose (Part A)

Secondary outcomes (2)

  1. Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

    Part B: PK: AUC(0-∞) of LY3437943

    Measured: Predose on Day 1 up to 71 days postdose (Part B)

  2. Part B: PK: Maximum Concentration (Cmax) of LY3437943

    Part B: PK: Cmax of LY3437943

    Measured: Predose on Day 1 up to 71 days postdose (Part B)

Timeline

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

  1. First posted25 Jul 2023
  2. Study start18 Jul 2023
  3. Primary completion25 Jul 2024
  4. Study completion25 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05959096
Sponsor's protocol ID
18532
Other IDs
J1I-MC-GZBS
Status last verified
Sep 2024
First submitted
17 Jul 2023
Last updated
1 Oct 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 in people with Healthy, run by Eli Lilly and Company at 1 site 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 3 inclusion and 5 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943 (time frame: Predose on Day 1 up to 43 days postdose (Part A)). The study lists 2 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 NCT05959096.

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 1 Oct 2024.

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