A Study of LY3971297 in Healthy Participants

NCT06148272 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 18771J4O-MC-EZHA
• Study Type: interventional
• Target: 225
• Locations: 3 countries
• Sites: 7

Brief 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. 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

Hypertension; Healthy; Obesity

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  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

  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

  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

Study Arms (8)

LY3971297 (Part A)

EXPERIMENTAL

Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants

Drug: LY3971297

LY3971297 (Part B)

EXPERIMENTAL

Multiple ascending doses of LY3971297 administered SC in healthy participants

Drug: LY3971297

LY3971297 (Part C)

EXPERIMENTAL

Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants

Drug: LY3971297

LY3971297 (Part D)

EXPERIMENTAL

Multiple ascending doses of LY3971297 administered SC

Drug: LY3971297

LY3971297 (Part E)

EXPERIMENTAL

Multiple doses of LY3971297 administered SC in healthy Japanese participants

Drug: LY3971297

Placebo (Part A, B, C, D, E, & G)

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

LY3971297 (Part F)

EXPERIMENTAL

Single doses of LY3971297 administered intravenously (IV) in healthy participants

Drug: LY3971297 IV

LY3971297 (Part G)

EXPERIMENTAL

Multiple doses of LY3971297 administered SC

Drug: LY3971297

Interventions

LY3971297 IV DRUG

Administered IV

LY3971297 (Part F)

LY3971297 DRUG

Administered SC

LY3971297 (Part A); LY3971297 (Part B); LY3971297 (Part C); LY3971297 (Part D); LY3971297 (Part E); LY3971297 (Part G)

Placebo DRUG

Administered SC

Placebo (Part A, B, C, D, E, & G)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

CenExel ACT

Anaheim, California, 92801, United States

RECRUITING

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

RECRUITING

ICON Early Phase Services

San Antonio, Texas, 78209, United States

RECRUITING

Hakata Clinic

Fukuoka, 812-0025, Japan

ACTIVE NOT RECRUITING

P-One Clinic

Hachiōji, 192-0071, Japan

ACTIVE NOT RECRUITING

Clinical Research Hospital Tokyo

Shinjuku-ku, 160-0004, Japan

ACTIVE NOT RECRUITING

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

RECRUITING

MeSH Terms

Conditions

Obesity; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 7, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); JP (3); US (3)