HealthyPhase 1NCT05444569
A Study of LY3537021 in Healthy Participants
A Phase 1 study testing LY3537021 and Liraglutide in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3537021 and Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Aug 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined through medical evaluation
- Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²)
- Males, or females who are not of childbearing potential.
- Capable of giving signed informed consent form
- Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine)
Who cannot join
- Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs
- History of malignancy within 5 years prior to screening
- Have evidence of significant active psychiatric disorder(s)
- Have undergone any form of bariatric surgery
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Are females who are lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.
- Conditions
- Healthy
- Being tested
- LY3537021, Liraglutide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537021Drug
Administered SC.
LiraglutideDrug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3537021 + Liraglutide (Part A) | Experimental | Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC. Receives: Drug: LY3537021; Drug: Liraglutide |
| Liraglutide + Placebo (Part A) | Experimental | Liraglutide administered SC followed by liraglutide in combination with placebo given SC. Receives: Drug: Liraglutide; Drug: Placebo |
| LY3537021 + Liraglutide & Placebo + Liraglutide (Part B) | Experimental | LY3537021 administered SC followed by liraglutide administered SC in treatment period 1.
Placebo administered SC followed by liraglutide administered SC in treatment period 2. Receives: Drug: LY3537021; Drug: Liraglutide; Drug: Placebo |
| Placebo + Liraglutide & LY3537021 + Liraglutide Part B) | Experimental | Placebo administered SC followed by liraglutide administered SC in treatment period 1.
LY3537021 administered SC followed by liraglutide administered SC in treatment period 2. Receives: Drug: LY3537021; Drug: Liraglutide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline up to Week 22
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 Aug 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 HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has two parts. Part A is parallel model and part B is crossover.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 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
- NCT05444569
- Sponsor's protocol ID
- 18449
- Other IDs
- J2R-MC-YAAC
- Status last verified
- Feb 2023
- First submitted
- 30 Jun 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants
- ClinicalTrials.gov ID
- NCT05444569
- Acronym / sponsor ID
- 18449
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 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 evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The study has two parts. Part A is parallel model and part B is crossover.
| Arm | Type | Receives |
|---|---|---|
| LY3537021 + Liraglutide (Part A) | Experimental | Drug: LY3537021, Drug: LiraglutideLiraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC. |
| Liraglutide + Placebo (Part A) | Experimental | Drug: Liraglutide, Drug: PlaceboLiraglutide administered SC followed by liraglutide in combination with placebo given SC. |
| LY3537021 + Liraglutide & Placebo + Liraglutide (Part B) | Experimental | Drug: LY3537021, Drug: Liraglutide, Drug: PlaceboLY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2. |
| Placebo + Liraglutide & LY3537021 + Liraglutide Part B) | Experimental | Drug: LY3537021, Drug: Liraglutide, Drug: PlaceboPlacebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who are overtly healthy as determined through medical evaluation
- Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²)
- Males, or females who are not of childbearing potential.
- Capable of giving signed informed consent form
- Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine)
Key exclusion criteria (6 listed)
- Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs
- History of malignancy within 5 years prior to screening
- Have evidence of significant active psychiatric disorder(s)
- Have undergone any form of bariatric surgery
- Have an abnormality in the 12-lead electrocardiogram (ECG)
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 |
|---|---|---|
| LY3537021Administered SC. | Drug | LY3537021 + Liraglutide & Placebo + Liraglutide (Part B), LY3537021 + Liraglutide (Part A), Placebo + Liraglutide & LY3537021 + Liraglutide Part B) |
| LiraglutideAdministered SC. | Drug | LY3537021 + Liraglutide & Placebo + Liraglutide (Part B), LY3537021 + Liraglutide (Part A), Liraglutide + Placebo (Part A), Placebo + Liraglutide & LY3537021 + Liraglutide Part B) |
| PlaceboAdministered SC. | Drug | LY3537021 + Liraglutide & Placebo + Liraglutide (Part B), Liraglutide + Placebo (Part A), Placebo + Liraglutide & LY3537021 + Liraglutide Part B) |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Week 22
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
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 1 Mar 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3537021 and Liraglutide in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 5 inclusion and 6 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 Mar 2023. 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 Singapore. 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?
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Week 22). 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 1 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.