A Phase 3 interventional study of Orforglipron and Placebo in Overweight, Prediabetic State and Prehypertension, sponsored by Eli Lilly and Company. Recruiting at 180 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.
Exclusion Criteria:
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive orforglipron orally followed by placebo orally
Drug: Orforglipron · Drug: Placebo
Participants will receive placebo orally followed by orforglipron orally
Drug: Orforglipron · Drug: Placebo
Administered orally
Also known as: LY3502970
Administered orally
Time to Onset of Obesity Related Complications or Class 1 Obesity
Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold
Time frame: Baseline to Week 104
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 104
Time to Onset of Waist-to-Height Ratio ≥0.6
Time frame: Baseline to Week 104
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 104
Time to Onset of Class 1 Obesity
Time frame: Baseline to Week 104
Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia
Time frame: Baseline to Week 104
Time to Onset of Type 2 Diabetes
Time frame: Baseline to Week 104
Percent Change from Baseline in Total Fat Mass
Time frame: Baseline, Week 104
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 104
Change from Baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, Week 104
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 104
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score
Time frame: Baseline, Week 104
Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron
Time frame: Week 4, 12, 24, 52, and 76
Showing the first 100 of 180 sites across 12 countries.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
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Eli Lilly and Company