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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05869903
Other study ID # 18559
Secondary ID J2A-MC-GZGP2022-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 5, 2023
Est. completion date September 24, 2027

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Orforglipron
Administered orally.
Placebo
Administered orally.

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Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Brazil,  China,  India,  Japan,  Korea, Republic of,  Puerto Rico,  Slovakia,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Percent Change from Baseline in Body Weight Baseline to Week 72
Secondary Mean Change from Baseline in Waist Circumference Baseline, Week 72
Secondary Mean Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72
Secondary Mean Percent Change from Baseline in Fasting non-HDL Cholesterol Baseline, Week 72
Secondary Mean Percent Change from Baseline in Fasting Triglycerides Baseline, Week 72
Secondary Mean Change from Baseline in Hemoglobin A1c (HbA1c) % Baseline, Week 72
Secondary Mean Change from Baseline in Fasting Glucose Baseline, Week 72
Secondary Mean Percent Change from Baseline in Fasting Insulin Baseline, Week 72
Secondary Mean Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 72
Secondary Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores Baseline, Week 72
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