Diabetes Mellitus, Type 2Phase 1NCT04143802
A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing LY3437943 and Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 4 sites in United States.
Trial summary
The main purpose of this study is to learn about the side effects of LY3437943 when given to 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY3437943 and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Dec 2019to 28 Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus
- Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
- Have had a stable body weight for the 3 months prior to randomization (<5% body weight change)
- Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive
- Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose
- Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal
Who cannot join
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
- Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
- Have a known clinically significant gastric emptying abnormality
- Have had an episode of severe hypoglycemia
- Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening
- Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3X upper limit of normal (ULN) at screening and/or Day -2
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
PRA International
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
About this study
Official title: A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Patients With Type 2 Diabetes Mellitus
The main purpose of this study is to learn about the side effects of LY3437943 when given to 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. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY3437943, Dulaglutide, 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.
LY3437943Drug
Administered SC
DulaglutideDrug
Also called LY2189265
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3437943 | Experimental | LY3437943 administered subcutaneously (SC) Receives: Drug: LY3437943 |
| Dulaglutide | Active comparator | Dulaglutide administered SC Receives: Drug: Dulaglutide |
| Placebo | 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 106
Secondary outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943
PK: AUC of LY3437943
Measured: Baseline through study completion (12 weeks)
PK: Maximum Concentration (Cmax) of LY3437943
PK: Cmax of LY3437943
Measured: Baseline through study completion (12 weeks)
Change from Baseline in Mean Daily Plasma Glucose (PG)
Change from baseline in mean daily PG from 6-point PG profile
Measured: Baseline through Day 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start18 Dec 2019
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
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 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
- 72 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
- NCT04143802
- Sponsor's protocol ID
- 17137
- Other IDs
- J1I-MC-GZBB
- Status last verified
- 15 Jan 2021
- First submitted
- 28 Oct 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urva S, Coskun T, Loh MT, Du Y, Thomas MK, Gurbuz S, Haupt A, Benson CT, Hernandez-Illas M, D'Alessio DA, Milicevic Z. LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Lancet. 2022 Nov 26;400(10366):1869-1881. doi: 10.1016/S0140-6736(22)02033-5. Epub 2022 Oct 27.
PubMed 36354040
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04143802
- Acronym / sponsor ID
- 17137
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 29 Oct 2019 (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 about the side effects of LY3437943 when given to 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. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3437943 | Experimental | Drug: LY3437943LY3437943 administered subcutaneously (SC) |
| Dulaglutide | Active comparator | Drug: DulaglutideDulaglutide administered SC |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus
- Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
- Have had a stable body weight for the 3 months prior to randomization (<5% body weight change)
- Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive
- Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose
Key exclusion criteria (6 listed)
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
- Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
- Have a known clinically significant gastric emptying abnormality
- Have had an episode of severe hypoglycemia
- Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening
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 |
| DulaglutideAlso: LY2189265Administered SC | Drug | Dulaglutide |
| PlaceboAdministered SC | Drug | Placebo |
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 106
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943
Time frame: Baseline through study completion (12 weeks)
PK: Maximum Concentration (Cmax) of LY3437943
Time frame: Baseline through study completion (12 weeks)
Change from Baseline in Mean Daily Plasma Glucose (PG)
Time frame: Baseline through Day 80
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 20 Jan 2021.
- Derived from this study: PubMed 36354040Urva S, Coskun T, Loh MT, Du Y, Thomas MK, Gurbuz S, Haupt A, Benson CT, Hernandez-Illas M, D'Alessio DA, Milicevic Z. LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Lancet. 2022 Nov 26;400(10366):1869-1881. doi: 10.1016/S0140-6736(22)02033-5. Epub 2022 Oct 27.
- Related InfoLink 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
4 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 and Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 4 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 6 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 106). 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 NCT04143802, 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 20 Jan 2021.