ACTIVE_NOT_RECRUITING

A Study of LY3537031 in Overweight, Obese, and Healthy Participants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants. Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 49 weeks excluding a screening period.

Official Title

A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers

Quick Facts

Study Start:2024-09-05
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06606106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a BMI within the range of:
  2. * Parts A and D: 27.0 to 45.0 kilogram per square meter (kg/m²)
  3. * Parts B and C: 22.0 to 26.9 kg/m²
  4. * Parts B and C: Weigh 60 kg (80 pounds (lbs)) or more at screening
  5. * Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
  6. * Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.
  1. * Have undergone any form of bariatric surgery
  2. * Participants who are lactating
  3. * Have taken medications that promote weight loss within 90 days before screening
  4. * Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL), 10.2 picomoles per liter (pmol/L))

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
United States
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
United States
Clinical Pharmacology of Miami
Miami, Florida, 33172
United States
QPS
Springfield, Missouri, 65802
United States
Fortrea Clinical Research Unit
Dallas, Texas, 75247
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-05
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-09-05
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Overweight
  • Obesity