New drug LY3971297 tested for obesity and hypertension safety
NCT ID NCT06148272
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 3 times
Summary
This early-stage study tests a new drug called LY3971297 in healthy volunteers, people with obesity and high blood pressure, and those with reduced kidney function. The main goal is to check for side effects and measure how the drug moves through the body. The study involves up to 225 participants and lasts up to 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY3971297
- What this could lead to
- If successful, this could lead to a new treatment option for obesity and high blood pressure.
- What could go wrong
- This is a very early Phase 1 trial focused on safety and dosing, not effectiveness. It is small and may not lead to a working treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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200 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CenExel ACT
Anaheim, California, 92801, United States
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Clinical Pharmacology of Miami
Miami, Florida, 33172, United States
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Clinical Research Hospital Tokyo
Shinjuku-ku, 160-0004, Japan
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Hakata Clinic
Fukuoka, 812-0025, Japan
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ICON Early Phase Services
San Antonio, Texas, 78209, United States
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Lilly Centre for Clinical Pharmacology
Singapore, 138623, Singapore
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P-One Clinic
Hachiōji, 192-0071, Japan
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