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 2026-11-05.
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.
294 studies on the registry are indexed under Obesity, Abdominal; 45 are open to participants now.
This study's planned enrollment of 2,001 is above the median of 58 across 234 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Compared within Obesity, Abdominal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. Choose a country and city above to see the rest.
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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Aug 2026 (actual). Primary completion is estimated for Aug 2029, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Orforglipron