Phase 3
N=559
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05971940 ↗Enrolled (actual)
559
Serious AEs
4.3%
Results posted
Apr 2026
Primary outcome: Primary: Change From Baseline in HbA1c — -0.15; -1.26; -1.59; -1.45 percentage of HbA1c — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Orforglipron (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c |
-0.15; -1.26; -1.59; -1.45 | <.001 sig |
| SECONDARY Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol) |
37.11; 78.15; 81.25; 78.99 | <.001 sig |
| SECONDARY Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol) |
18.56; 66.39; 68.75; 68.91 | <.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose (FSG) |
-1.1; -30.6; -37.4; -37.8 | <.001 sig |
| SECONDARY Percent Change From Baseline in Body Weight |
-1.6; -4.7; -6.1; -7.9 | <.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-1.3; -4.4; -5.5; -7.3 | <.001 sig |
| SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol |
3.19; -1.82; -4.80; -7.91 | 0.100 |
| SECONDARY Percent Change From Baseline in Triglycerides |
0.0; -9.1; -16.5; -14.0 | 0.072 |
| SECONDARY Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) |
-17.6; -43.6; -56.0; -58.1 | <.001 sig |
| SECONDARY Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction |
14.58; 47.06; 58.56; 66.39 | <.001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) |
-0.5; -3.2; -6.1; -6.0 | 0.031 sig |
| SECONDARY Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores |
2.25; 2.06; 2.21; 1.58; 0.09; 0.11 | 0.801 |
Summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.
Eligibility Criteria
Inclusion Criteria
- Have Type 2 Diabetes
- Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
- Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
- Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
- Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion Criteria
- Have Type 1 Diabetes
- Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
- Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have New York Heart Association functional classification IV congestive heart failure.
- Have acute or chronic pancreatitis
Data sourced from ClinicalTrials.gov (NCT05971940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.