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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
California
CenExel ACT
RECRUITING
Anaheim
Texas
ICON Early Phase Services
RECRUITING
San Antonio
Other Locations
Japan
Hakata Clinic
RECRUITING
Fukuoka
P-One Clinic
RECRUITING
Hachiōji
Clinical Research Hospital Tokyo
RECRUITING
Shinjuku-ku
Singapore
Lilly Centre for Clinical Pharmacology
RECRUITING
Singapore
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 225
Treatments
Experimental: LY3971297 (Part A)
Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants
Experimental: LY3971297 (Part B)
Multiple ascending doses of LY3971297 administered SC in healthy participants
Experimental: LY3971297 (Part C)
Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants
Experimental: LY3971297 (Part D)
Multiple ascending doses of LY3971297 administered SC
Experimental: LY3971297 (Part E)
Multiple doses of LY3971297 administered SC in healthy Japanese participants
Placebo_comparator: Placebo (Part A, B, C, D, E, & G)
Placebo administered SC
Experimental: LY3971297 (Part F)
Single doses of LY3971297 administered intravenously (IV) in healthy participants
Experimental: LY3971297 (Part G)
Multiple doses of LY3971297 administered SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov