Clinical Trials/NCT05931380

NCT05931380

Completed

Phase 3

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease

Eli Lilly and Company16 sites in 1 country238 target enrollmentJuly 31, 2023

ConditionsObesity

InterventionsOrforglipron Placebo

DrugsOrforglipron Placebo

Overview

Phase: Phase 3
Intervention: Orforglipron
Conditions: Obesity
Sponsor: Eli Lilly and Company
Enrollment: 238
Locations: 16
Primary Endpoint: Mean Percent Change in Body Weight
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.

Registry

clinicaltrials.gov

Start Date

July 31, 2023

End Date

June 19, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants with a BMI ≥27 kg/m² and \<35 kg/m² and at least 2 obesity-related health problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants).
•Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
•Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
•Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•No male contraception is required except in compliance with specific local government study requirements.

Exclusion Criteria

•For participants with Type 2 Diabetes (T2D):
•Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
•Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening.
•Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening.
•Have a known clinically significant gastric emptying abnormality.
•For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %.
•Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
•Have chronic kidney disease.
•Have lupus or rheumatoid arthritis.
•Have the following cardiovascular conditions within 90 days prior to screening.

Arms & Interventions

Orforglipron Dose 1

Participants will receive orforglipron orally.

Intervention: Orforglipron

Orforglipron Dose 2

Participants will receive orforglipron orally.

Intervention: Orforglipron

Orforglipron Dose 3

Participants will receive orforglipron orally.

Intervention: Orforglipron

Placebo

Participants will receive placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Mean Percent Change in Body Weight

Time Frame: Baseline, Week 72

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time Frame: Baseline to Week 72

Secondary Outcomes

Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Baseline to Week 72)
Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Baseline to Week 72)
Percentage of Participants Who Achieve ≥20% Body Weight Reduction(Baseline to Week 72)
Mean Change from Baseline in Body Mass Index (BMI)(Baseline, Week 72)
Percentage of Participants Who Had Improvements in Hypertension(Baseline to Week 72)
Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)(Baseline to Week 72)
Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):(Baseline to Week 72)
Mean Change from Baseline in Visceral Adipose Tissue (VAT)(Baseline, Week 72)
Mean Change from Baseline in Waist Circumference at Umbilical Level(Baseline, Week 72)
Mean Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 72)
Mean Change from Baseline in non-High Density Lipoprotein (HDL)(Baseline, Week 72)
Mean Change from Baseline in HDL(Baseline, Week 72)
Mean Change from Baseline in Triglycerides(Baseline, Week 72)
Mean Change from Baseline in Fasting Glucose(Baseline, Week 72)
Mean Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 72)
Mean Change from Baseline in High-sensitivity C-reactive Protein(Baseline, Week 72)
Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores(Baseline, Week 72)
Mean Change from Baseline in IMPACT of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function, Physical, and Psychosocial Composite Score(Baseline, Week 72)
Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)(Baseline to Week 72)
Pharmacokinetics (PK): Plasma Concentration of Orforglipron(Baseline to Week 72)