ObesityPhase 1NCT05445232
A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants
A Phase 1 study testing LY3437943, Midazolam and Warfarin in people with Obesity, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- LY3437943, Midazolam and Warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2022to 24 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)
- Male and female participants of childbearing potential who agree to use contraceptive methods
Who cannot join
- Have a history of diabetes or current diagnosis of diabetes
- History or presence of a of significant bleeding disorder
- Participants with significant comorbidity
- Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance Dallas
Dallas, Texas, 75247
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Multiple-Dose Drug-Drug Interaction Study to Determine the Effect of LY3437943 on Drug Metabolizing Enzymes
The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.
- Conditions
- Obesity
- Keywords
- Overweight, Obesity, Drug Interaction, Cocktail, Pharmacokinetic
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3437943Drug
Administered SC.
MidazolamDrug
Administered orally.
WarfarinDrug
Administered orally.
CaffeineDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3437943 + Drug Cocktail | Experimental | Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1.
At weeks 8, 12, \& 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2. Receives: Drug: LY3437943; Drug: Midazolam; Drug: Warfarin; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
PK: AUC[0-∞] of Midazolam
Measured: Predose up to 24 hours postdose
PK: Maximum Observed Concentration (Cmax) of Midazolam
PK: Cmax of Midazolam
Measured: Predose up to 24 hours postdose
PK: AUC[0-∞] of Warfarin
PK: AUC[0-∞] of Warfarin
Measured: Predose up to 96 hours postdose
PK: Cmax of Warfarin
PK: Cmax of Warfarin
Measured: Predose up to 96 hours postdose
PK: AUC[0-∞] of Caffeine
PK: AUC[0-∞] of Caffeine
Measured: Predose up to 48 hours postdose
PK: Cmax of Caffeine
PK: Cmax of Caffeine
Measured: Predose up to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start8 Jul 2022
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445232
- Sponsor's protocol ID
- 18476
- Other IDs
- J1I-MC-GZBI
- Status last verified
- 1 Apr 2023
- First submitted
- 1 Jul 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Drug-Drug Interaction Study to Determine the Effect of LY3437943 on Drug Metabolizing Enzymes
- ClinicalTrials.gov ID
- NCT05445232
- Acronym / sponsor ID
- 18476
- Conditions
- Obesity
- Keywords
- Overweight, Obesity, Drug Interaction, Cocktail, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY3437943 + Drug Cocktail | Experimental | Drug: LY3437943, Drug: Midazolam, Drug: Warfarin, Drug: CaffeineMidazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1. At weeks 8, 12, \& 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)
- Male and female participants of childbearing potential who agree to use contraceptive methods
Key exclusion criteria (4 listed)
- Have a history of diabetes or current diagnosis of diabetes
- History or presence of a of significant bleeding disorder
- Participants with significant comorbidity
- Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3437943Administered SC. | Drug | LY3437943 + Drug Cocktail |
| MidazolamAdministered orally. | Drug | LY3437943 + Drug Cocktail |
| WarfarinAdministered orally. | Drug | LY3437943 + Drug Cocktail |
| CaffeineAdministered orally. | Drug | LY3437943 + Drug Cocktail |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
Time frame: Predose up to 24 hours postdose
PK: AUC[0-∞] of Midazolam
PK: Maximum Observed Concentration (Cmax) of Midazolam
Time frame: Predose up to 24 hours postdose
PK: Cmax of Midazolam
PK: AUC[0-∞] of Warfarin
Time frame: Predose up to 96 hours postdose
PK: AUC[0-∞] of Warfarin
PK: Cmax of Warfarin
Time frame: Predose up to 96 hours postdose
PK: Cmax of Warfarin
PK: AUC[0-∞] of Caffeine
Time frame: Predose up to 48 hours postdose
PK: AUC[0-∞] of Caffeine
PK: Cmax of Caffeine
Time frame: Predose up to 48 hours postdose
PK: Cmax of Caffeine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3437943, Midazolam and Warfarin in people with Obesity, 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 4 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 18 Apr 2023. 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 Zero to Infinity (AUC[0-∞]) of Midazolam (time frame: Predose up to 24 hours 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?
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 18 Apr 2023.