A Study of LY3971297 in Healthy Participants and Participants With Obesity and Hypertension

Healthy Clinical Trial

Official title:

A Single-ascending and Multiple-ascending Dose Study of LY3971297 in Healthy Participants and Participants With Obesity and Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148272
• Other study ID #: 18771
• Secondary ID: J4O-MC-EZHA
• Status: Recruiting
• Phase: Phase 1
• Start date: December 7, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This is a 5-part study. The study duration will be approximately 60 days for Part A and approximately 90 days for Parts B, C, D, and E.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• For Parts A, B, C, E, Overtly healthy males or females as determined by medical history and physical examination.

• For Parts A, B, C, E, have a screening body mass index (BMI) in the range of 18.5 to 35 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 Part D, participants with obesity and hypertension must have a stable dose of antihypertensive 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 cm for men and at least 89 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.

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 BP of less than 100 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 Part D, has concurrent or anticipated use of long-acting nitrates or NO donors.

• For Part D, has concurrent or anticipated use of beta blockers.

• For Part D, has current use of more than 3 mechanism of actions for treatment of hypertension.

Related Conditions & MeSH terms

• Healthy
• Hypertension
• Obesity

Intervention

Drug:
• LY3971297
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore
United States	CenExel ACT	Anaheim	California
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: 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: 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
Primary	Part B, C, D, & E: 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: 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
Secondary	Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297	PK: AUC of LY3971297	Predose on day 1 up to 29 days post dose for Part A and predose on day 1 up to 57 days post dose for Part B, C, D, and E
Secondary	PK: Maximum Observed Drug Concentration (Cmax) of LY3971297	PK: Cmax of LY3971297	Predose on day 1 up to 29 days post dose for Part A and predose on day 1 up to 57 days post dose for Part B, C, D, and E