HealthyPhase 1NCT06132126
A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing LY3938577 and Insulin degludec in people with Healthy and Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 2 Diabetes Mellitus
- What is being tested?
- LY3938577 and Insulin degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Nov 2023to 28 Jun 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
- Male and female participants who are overtly healthy as determined by medical evaluation (Part A)
- Participants with T2DM diagnosed greater than 1 year before enrollment (Part A and Part B)
- Have a body mass index within the range of 18.5 to less than or equal to (<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants.
- Male or female participants of nonchildbearing potential
Who cannot join
- Have proliferative retinopathy or maculopathy and/or severe neuropathy
- Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months
- Have received chronic systemic glucocorticoid therapy in the past 3 months
- Are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
CenExel ACT
Anaheim, California, 92801
Labcorp CRU
Dallas, Texas, 75247
Qps-Mra, Llc
Miami, Florida, 33143
About this study
Official title: A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Being tested
- LY3938577, Placebo, Insulin degludec
- 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.
LY3938577Drug
Administered SC.
PlaceboDrug
Administered SC.
Insulin degludecDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3938577 (Part A) | Experimental | LY3938577 administered Subcutaneously (SC). Receives: Drug: LY3938577 |
| Placebo (Part A) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| Insulin degludec (Part A) | Active comparator | Insulin degludec administered SC. Receives: Drug: Insulin degludec |
| LY3938577 (Part B) | Experimental | LY3938577 administered SC. Receives: Drug: LY3938577 |
| Insulin degludec (Part B) | Active comparator | Insulin degludec administered SC. Receives: Drug: Insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Measured: Baseline up to 16 days
Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Measured: Baseline up to 44 days
Part A: Incidence of Hypoglycemia
Measured: Baseline up to 16 days
Part B: Incidence of Hypoglycemia
Measured: Baseline up to 44 days
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Measured: Baseline up to 16 days
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Measured: Baseline up to 44 days
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Measured: Baseline up to 16 days
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Measured: Baseline up to 44 days
Secondary outcomes (1)
Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)
Measured: Part A: Predose up to 16 Days and Part B: Predose up to 44 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start17 Nov 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 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
- NCT06132126
- Sponsor's protocol ID
- 18779
- Other IDs
- J4P-MC-IYAA
- Status last verified
- Jul 2024
- First submitted
- 10 Nov 2023
- Last updated
- 24 Jul 2024
- Results posted
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06132126
- Acronym / sponsor ID
- 18779
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 15 Nov 2023 (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 assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LY3938577 (Part A) | Experimental | Drug: LY3938577LY3938577 administered Subcutaneously (SC). |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| Insulin degludec (Part A) | Active comparator | Drug: Insulin degludecInsulin degludec administered SC. |
| LY3938577 (Part B) | Experimental | Drug: LY3938577LY3938577 administered SC. |
| Insulin degludec (Part B) | Active comparator | Drug: Insulin degludecInsulin degludec administered SC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants who are overtly healthy as determined by medical evaluation (Part A)
- Participants with T2DM diagnosed greater than 1 year before enrollment (Part A and Part B)
- Have a body mass index within the range of 18.5 to less than or equal to (<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants.
- Male or female participants of nonchildbearing potential
Key exclusion criteria (4 listed)
- Have proliferative retinopathy or maculopathy and/or severe neuropathy
- Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months
- Have received chronic systemic glucocorticoid therapy in the past 3 months
- Are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product.
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 |
|---|---|---|
| LY3938577Administered SC. | Drug | LY3938577 (Part A), LY3938577 (Part B) |
| PlaceboAdministered SC. | Drug | Placebo (Part A) |
| Insulin degludecAdministered SC. | Drug | Insulin degludec (Part A), Insulin degludec (Part B) |
Primary outcome
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Time frame: Baseline up to 16 days
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Time frame: Baseline up to 44 days
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Part A: Incidence of Hypoglycemia
Time frame: Baseline up to 16 days
Part B: Incidence of Hypoglycemia
Time frame: Baseline up to 44 days
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Baseline up to 16 days
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Baseline up to 44 days
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time frame: Baseline up to 16 days
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time frame: Baseline up to 44 days
1 secondary outcome
Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)
Time frame: Part A: Predose up to 16 Days and Part B: Predose up to 44 Days
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 24 Jul 2024.
- A Study to Investigate the Safety and Tolerability of LY3938577 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
3 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 LY3938577 and Insulin degludec in people with Healthy and Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 3 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 4 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration (time frame: Baseline up to 16 days). The study lists 8 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 24 Jul 2024.