HealthyPhase 1NCT06148272
A Study of LY3971297 in Healthy Participants
A Phase 1 study testing LY3971297 and LY3971297 IV in people with Healthy and Obesity, run by Eli Lilly and Company at 7 sites in 3 countries.
Trial summary
The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Healthy, Obesity, Hypertension
- What is being tested?
- LY3971297 and LY3971297 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 7 Dec 2023to 18 Aug 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Parts A, B, C, E, and F: Overtly healthy males or females as determined by medical history and physical examination
- For Parts A, B, C, E, and F: Have a screening body mass index (BMI) in the range of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening
- For Part C, to qualify as Chinese for the purpose of this study, all the participants' biological grandparents must be of exclusive Chinese descent and born in China
- For Part D, participants must have a stable dose of medications within the past 3 months prior to screening
- For Part D, obesity BMI in the range of 30 to 40 kg/m², inclusive, with a waist circumference of at least 102 centimeter (cm) for men and at least 89 cm for women for participants of US sites only. For participants of Singaporean, South Asian, Japanese, and/or Chinese Origin at sites outside the US, the BMI range is 27 to 40 kg/m2 and the waist circumference is at least 90 cm for men and at least 80 cm for women
- For Part E, to qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participants' biological grandparents must be of exclusive Japanese descent and born in Japan
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- Male participants must agree to adhere to contraception restrictions and female participants must be women not of childbearing potential
- For Part G, have a screening BMI in the range of 18.5 to 40 kg/m², inclusive, with no significant weight gain or loss in the past 3 months prior to screening
- For Part G, participants have a decreased estimated glomerular filtration rate (eGFR)
- For Parts D and G, participants are allowed to have stable background treatment for hypertension, type 2 diabetes mellitus (on oral drug therapy and/or long-acting insulin), dyslipidemia (on statin therapy) and/or hypothyroidism as determined by the investigator
- For Part G, Participants should be on a stable dose of angiotensin converting enzyme inhibitor or angiotensin II receptor blocker
Who cannot join
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- Have known or ongoing psychiatric disorders that, in the opinion of the investigator, increases the risks associated with study participation
- Have blood pressure and/or pulse rate constituting a risk as determined by the investigator
- Have a systolic blood pressure (BP) of less than 100 millimeters of mercury (mmHg)
- Diagnosed with orthostatic hypotension defined as a decrease in systolic blood pressure of equal to or greater than 20 mmHg or a decrease in diastolic blood pressure of equal to or greater than 10 mmHg when compared with BP from the supine position
- For US sites: have donated blood of more than 500 mL within the previous 3 months of screening or intend to donate blood during the course of the study
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- For Singapore sites: Have donated blood of more than 450 mL or more in the past 3 months or provided any blood donation within the past 1 month before screening
- Consume more than 10 cigarettes per day (or the equivalent) or are unable or unwilling to abstain from nicotine
- Have alcohol intake that exceeds recommended alcohol consumption limits per local regulation or are unwilling to stop alcohol consumption 24 hours prior to dosing until discharge
- For Part D, has concurrent use or anticipated use of phosphodiesterase 5 inhibitor such as vardenafil, tadalafil, and sildenafil, soluble guanylyl cyclase activators (such as riociguat and vericiguat)
- For Parts D and G, has concurrent or anticipated use of long-acting nitrates or nitric oxide (NO) donors
- For Part D, has current use of more than 3 mechanism of actions for treatment of hypertension
- For Part G, has previous or current diagnosis of primary glomerulopathy, vasculitic renal disease, prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis, or anti-neutrophil cytoplasm antibody-associated vasculitis
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
CenExel ACT
Anaheim, California, 92801
Clinical Pharmacology of Miami
Miami, Florida, 33172
ICON Early Phase Services
San Antonio, Texas, 78209
Japan3 sites
Hakata Clinic
Fukuoka, 812-0025
P-One Clinic
Hachiōji, 192-0071
Clinical Research Hospital Tokyo
Shinjuku-ku, 160-0004
About this study
Official title: A Single-ascending and Multiple-ascending Dose Study of LY3971297 in Healthy Participants and Participants With Obesity and Hypertension and Participants With Decreased Estimated Glomerular Filtration Rate
The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.
- Conditions
- Healthy, Obesity, Hypertension
- Being tested
- LY3971297, Placebo, LY3971297 IV
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3971297Drug
Administered SC
PlaceboDrug
Administered SC
LY3971297 IVDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3971297 (Part A) | Experimental | Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants Receives: Drug: LY3971297 |
| LY3971297 (Part B) | Experimental | Multiple ascending doses of LY3971297 administered SC in healthy participants Receives: Drug: LY3971297 |
| LY3971297 (Part C) | Experimental | Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants Receives: Drug: LY3971297 |
| LY3971297 (Part D) | Experimental | Multiple ascending doses of LY3971297 administered SC Receives: Drug: LY3971297 |
| LY3971297 (Part E) | Experimental | Multiple doses of LY3971297 administered SC in healthy Japanese participants Receives: Drug: LY3971297 |
| Placebo (Part A, B, C, D, E, & G) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY3971297 (Part F) | Experimental | Single doses of LY3971297 administered intravenously (IV) in healthy participants Receives: Drug: LY3971297 IV |
| LY3971297 (Part G) | Experimental | Multiple doses of LY3971297 administered SC Receives: Drug: LY3971297 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and F: 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
Part A and F: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline (Day of Exposure) to Day 29 post-dose
Part B, C, D, E, & G: 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
Part B, C, D, E, \& G: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline (Day of Exposure) to Day 57 post-dose
Part F: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Part F: PK: AUC of LY3971297
Measured: Baseline Up to Day 29 post-dose for Part F
Part F: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Part F: PK: Cmax of LY3971297
Measured: Baseline Up to Day 29 post-dose for Part F
Secondary outcomes (2)
Part B, C, D, E, and G: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Part B, C, D, E, and G: PK: AUC of LY3971297
Measured: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
Part B, C, D, E, and G: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Part B, C, D, E, and G: PK: Cmax of LY3971297
Measured: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start7 Dec 2023
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148272
- Sponsor's protocol ID
- 18771
- Other IDs
- J4O-MC-EZHA
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2023
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-ascending and Multiple-ascending Dose Study of LY3971297 in Healthy Participants and Participants With Obesity and Hypertension and Participants With Decreased Estimated Glomerular Filtration Rate
- ClinicalTrials.gov ID
- NCT06148272
- Acronym / sponsor ID
- 18771
- Conditions
- Healthy, Obesity, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 28 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 purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| LY3971297 (Part A) | Experimental | Drug: LY3971297Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants |
| LY3971297 (Part B) | Experimental | Drug: LY3971297Multiple ascending doses of LY3971297 administered SC in healthy participants |
| LY3971297 (Part C) | Experimental | Drug: LY3971297Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants |
| LY3971297 (Part D) | Experimental | Drug: LY3971297Multiple ascending doses of LY3971297 administered SC |
| LY3971297 (Part E) | Experimental | Drug: LY3971297Multiple doses of LY3971297 administered SC in healthy Japanese participants |
| Placebo (Part A, B, C, D, E, & G) | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| LY3971297 (Part F) | Experimental | Drug: LY3971297 IVSingle doses of LY3971297 administered intravenously (IV) in healthy participants |
| LY3971297 (Part G) | Experimental | Drug: LY3971297Multiple doses of LY3971297 administered SC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For Parts A, B, C, E, and F: Overtly healthy males or females as determined by medical history and physical examination
- For Parts A, B, C, E, and F: Have a screening body mass index (BMI) in the range of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening
- For Part C, to qualify as Chinese for the purpose of this study, all the participants' biological grandparents must be of exclusive Chinese descent and born in China
- For Part D, participants must have a stable dose of medications within the past 3 months prior to screening
- For Part D, obesity BMI in the range of 30 to 40 kg/m², inclusive, with a waist circumference of at least 102 centimeter (cm) for men and at least 89 cm for women for participants of US sites only. For participants of Singaporean, South Asian, Japanese, and/or Chinese Origin at sites outside the US, the BMI range is 27 to 40 kg/m2 and the waist circumference is at least 90 cm for men and at least 80 cm for women
Key exclusion criteria (13 listed)
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- Have known or ongoing psychiatric disorders that, in the opinion of the investigator, increases the risks associated with study participation
- Have blood pressure and/or pulse rate constituting a risk as determined by the investigator
- Have a systolic blood pressure (BP) of less than 100 millimeters of mercury (mmHg)
- Diagnosed with orthostatic hypotension defined as a decrease in systolic blood pressure of equal to or greater than 20 mmHg or a decrease in diastolic blood pressure of equal to or greater than 10 mmHg when compared with BP from the supine position
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 |
|---|---|---|
| LY3971297Administered SC | Drug | LY3971297 (Part A), LY3971297 (Part B), LY3971297 (Part C), LY3971297 (Part D), LY3971297 (Part E), LY3971297 (Part G) |
| PlaceboAdministered SC | Drug | Placebo (Part A, B, C, D, E, & G) |
| LY3971297 IVAdministered IV | Drug | LY3971297 (Part F) |
Primary outcome
Part A and F: 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 (Day of Exposure) to Day 29 post-dose
Part A and F: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part B, C, D, E, & G: 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 (Day of Exposure) to Day 57 post-dose
Part B, C, D, E, \& G: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part F: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Time frame: Baseline Up to Day 29 post-dose for Part F
Part F: PK: AUC of LY3971297
Part F: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Time frame: Baseline Up to Day 29 post-dose for Part F
Part F: PK: Cmax of LY3971297
2 secondary outcomes
Part B, C, D, E, and G: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Time frame: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
Part B, C, D, E, and G: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Time frame: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
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 21 Sep 2026.
- 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3971297 and LY3971297 IV in people with Healthy and Obesity, run by Eli Lilly and Company at 7 sites in 3 countries.
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 11 inclusion and 13 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Japan, 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?
Part A and F: 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 (Day of Exposure) to Day 29 post-dose). The study lists 4 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 21 Sep 2026.