Diabetes Mellitus, Type 2Phase 1NCT05377333
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
A Phase 1 study testing LY3457263 and Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY3457263 and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jun 2022to 22 Nov 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with type 2 diabetes (T2D) at least 6 months before screening
- Participants treated for T2D with diet and exercise, with or without metformin
- Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%
- Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Who cannot join
- Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young
- Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy
- Have known allergies to GLP-1 receptor agonists
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CenExel ACT
Anaheim, California, 92801
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Atlanta Center of Medical Research
Atlanta, Georgia, 30331 2012
CenExel-HRI
Berlin, New Jersey, 08009
Qps-Mra, Llc
South Miami, Florida, 33143
About this study
Official title: Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 Alone and in Combination With GLP-1 RA in Patients With Type 2 Diabetes
The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY3457263, Placebo, Dulaglutide
- 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.
LY3457263Drug
Administered SC.
PlaceboDrug
Administered SC.
DulaglutideDrug
Also called LY2189265
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3457263 (Alone) | Experimental | LY3457263 administered subcutaneously (SC). Receives: Drug: LY3457263 |
| Placebo (Alone) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| LY3457263 + Dulaglutide | Experimental | LY3457263 in combination with dulaglutide administered SC. Receives: Drug: LY3457263; Drug: Dulaglutide |
| Placebo + Dulaglutide | Experimental | Placebo in combination with dulaglutide administered SC. Receives: Drug: Placebo; Drug: Dulaglutide |
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, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Predose up to 16 weeks
Secondary outcomes (1)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263
PK: AUC of LY3457263
Measured: Pre-dose on Day 1 up to 85 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start2 Jun 2022
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 94 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
- NCT05377333
- Sponsor's protocol ID
- 18129
- Other IDs
- J1R-MC-GZFB
- Status last verified
- Jan 2024
- First submitted
- 16 May 2022
- Last updated
- 11 Jan 2024
- 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 Alone and in Combination With GLP-1 RA in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05377333
- Acronym / sponsor ID
- 18129
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 17 May 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 investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3457263 (Alone) | Experimental | Drug: LY3457263LY3457263 administered subcutaneously (SC). |
| Placebo (Alone) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| LY3457263 + Dulaglutide | Experimental | Drug: LY3457263, Drug: DulaglutideLY3457263 in combination with dulaglutide administered SC. |
| Placebo + Dulaglutide | Experimental | Drug: Placebo, Drug: DulaglutidePlacebo in combination with dulaglutide administered SC. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with type 2 diabetes (T2D) at least 6 months before screening
- Participants treated for T2D with diet and exercise, with or without metformin
- Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%
- Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Key exclusion criteria (4 listed)
- Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young
- Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy
- Have known allergies to GLP-1 receptor agonists
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 |
|---|---|---|
| LY3457263Administered SC. | Drug | LY3457263 (Alone), LY3457263 + Dulaglutide |
| PlaceboAdministered SC. | Drug | Placebo (Alone), Placebo + Dulaglutide |
| DulaglutideAlso: LY2189265Administered SC. | Drug | LY3457263 + Dulaglutide, Placebo + Dulaglutide |
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: Predose up to 16 weeks
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
1 secondary outcome
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263
Time frame: Pre-dose on Day 1 up to 85 days post-dose
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 11 Jan 2024.
- 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
5 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 LY3457263 and Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 5 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 5 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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: Predose up to 16 weeks). 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 11 Jan 2024.