HealthyPhase 1NCT04586907
A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing LY3537021 in people with Healthy and Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to learn more about the safety of LY3537021 and any side effects that might be associated with it in healthy participants and participants with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 2 Diabetes Mellitus
- What is being tested?
- LY3537021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Nov 2020to 30 Nov 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy males or females not of childbearing potential, as determined through medical history and physical examination
- Contraceptive use by men should also be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Have a body mass index of 18.5 to 40 kilograms per square meter (kg/m²), inclusive
- Have hemoglobin A1c level of less than or equal to (≤)6.5 percent (%)
- Patients with Type 2 Diabetes Mellitus (T2DM):
- Have T2DM for at least 6 months
- For Part A, have a hemoglobin A1c value at screening of 6.5% to 11% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening. For Part B, have hemoglobin A1c value at screening of 6.5% to 10% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening with or without 1 other OAM, such as DPP-IV inhibitors, SGLT-2 inhibitors, or sulfonylureas
Who cannot join
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
- Have a history of malignancy within 5 years prior to screening
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
- Have evidence of significant active psychiatric disorder(s) as determined by the investigator
- Have undergone any form of bariatric surgery
- Have donated blood of 450 milliliters (mL) or more in the past 3 months or any blood donation within the past month from screening
Show all 12Show fewer
- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65 years) and 14 units per week (females and males above 65 years), or are unwilling to stop alcohol consumption 24 hours prior to dosing until discharge from the investigative site
- Smoke >10 cigarettes per day or the equivalent or are unable or unwilling to refrain from nicotine during investigative site admission
- Patients with T2DM:
- Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
- Are currently treated with or within the past 3 months had treatment with GLP-1 receptor agonists, or insulin
- Have had severe hypoglycemic event in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3537021 in Healthy Participants and Patients With Type 2 Diabetes Mellitus
The main purpose of this study is to learn more about the safety of LY3537021 and any side effects that might be associated with it in healthy participants and participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3537021 gets into the bloodstream and how long the body takes to eliminate it.
This study will last up to about 19 weeks including screening period.
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Being tested
- LY3537021, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537021Drug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3537021 (Part A/Healthy) | Experimental | LY3537021 administered subcutaneously (SC) to healthy participants. Receives: Drug: LY3537021 |
| LY3537021 (Part A/Type 2 Diabetes) | Experimental | LY3537021 administered SC to participants with type 2 diabetes mellitus (T2DM). Receives: Drug: LY3537021 |
| Placebo (Part A) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| LY3537021 (Part B/Healthy) | Experimental | LY3537021 administered SC to healthy participants. Receives: Drug: LY3537021 |
| LY3537021 (Part B/Type 2 Diabetes) | Experimental | LY3537021 administered SC to participants with T2DM. Receives: Drug: LY3537021 |
| Placebo (Part B) | Placebo comparator | Placebo administered SC. Receives: 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Day 119 (Part A) and Day 57 (Part B)
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537021
PK: AUC of LY3537021
Measured: Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)
PK: Maximum Concentration (Cmax) of LY3537021
PK: Cmax of LY3537021
Measured: Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start23 Nov 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 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
- NCT04586907
- Sponsor's protocol ID
- 17730
- Other IDs
- J2R-MC-YAAB
- Status last verified
- Dec 2021
- First submitted
- 12 Oct 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roell W, Alsina-Fernandez J, Qu H, Coskun T, Benson C, Haupt A, Kelly RP, O'Farrell L, Sloop KW, Steele JP, Ficorilli J, Regmi A, Rettiganti M, Urva S, Mather KJ, Pratt E. Long-acting GIPR agonist LY3537021 reduces body weight and fasting blood glucose in patients with T2D: Preclinical development and phase 1 randomized ascending dose studies. Mol Metab. 2026 Jan;103:102298. doi: 10.1016/j.molmet.2025.102298. Epub 2025 Dec 12.
PubMed 41391569
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3537021 in Healthy Participants and Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04586907
- Acronym / sponsor ID
- 17730
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 Oct 2020 (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 learn more about the safety of LY3537021 and any side effects that might be associated with it in healthy participants and participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3537021 gets into the bloodstream and how long the body takes to eliminate it.
This study will last up to about 19 weeks including screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY3537021 (Part A/Healthy) | Experimental | Drug: LY3537021LY3537021 administered subcutaneously (SC) to healthy participants. |
| LY3537021 (Part A/Type 2 Diabetes) | Experimental | Drug: LY3537021LY3537021 administered SC to participants with type 2 diabetes mellitus (T2DM). |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| LY3537021 (Part B/Healthy) | Experimental | Drug: LY3537021LY3537021 administered SC to healthy participants. |
| LY3537021 (Part B/Type 2 Diabetes) | Experimental | Drug: LY3537021LY3537021 administered SC to participants with T2DM. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are overtly healthy males or females not of childbearing potential, as determined through medical history and physical examination
- Contraceptive use by men should also be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Have a body mass index of 18.5 to 40 kilograms per square meter (kg/m²), inclusive
- Have hemoglobin A1c level of less than or equal to (≤)6.5 percent (%)
- Have T2DM for at least 6 months
Key exclusion criteria (12 listed)
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
- Have a history of malignancy within 5 years prior to screening
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
- Have evidence of significant active psychiatric disorder(s) as determined by the investigator
- Have undergone any form of bariatric surgery
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 (Part A/Healthy), LY3537021 (Part A/Type 2 Diabetes), LY3537021 (Part B/Healthy), LY3537021 (Part B/Type 2 Diabetes) |
| PlaceboAdministered SC. | Drug | Placebo (Part A), Placebo (Part B) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Day 119 (Part A) and Day 57 (Part B)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537021
Time frame: Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)
PK: Maximum Concentration (Cmax) of LY3537021
Time frame: Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)
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 17 Dec 2021.
- Derived from this study: PubMed 41391569Roell W, Alsina-Fernandez J, Qu H, Coskun T, Benson C, Haupt A, Kelly RP, O'Farrell L, Sloop KW, Steele JP, Ficorilli J, Regmi A, Rettiganti M, Urva S, Mather KJ, Pratt E. Long-acting GIPR agonist LY3537021 reduces body weight and fasting blood glucose in patients with T2D: Preclinical development and phase 1 randomized ascending dose studies. Mol Metab. 2026 Jan;103:102298. doi: 10.1016/j.molmet.2025.102298. Epub 2025 Dec 12.
- A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes MellitusLink provided by the sponsor.
- 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 in people with Healthy and Type 2 Diabetes Mellitus, 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 7 inclusion and 12 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 17 Dec 2021. 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. Some participants in this study may receive a placebo. 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 119 (Part A) and Day 57 (Part B)). 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 NCT04586907, which also lists 1 linked publication.
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 17 Dec 2021.