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NCT06045221 (Orforglipron in Type 2 Diabetes Inadequately Controlled With…): BVCT ex-ante prediction vs. reported outcome

On 30 Mar 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 17 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (comparable efficacy and tolerability of orforglipron 36mg vs. oral semaglutide 50mg).

Clinical Trial

NCTID
NCT06045221
Acronym
ACHIEVE-3
Drug Name
Orforglipron
Drug MoA
oral GLP1R agonist
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Type 2 Diabetes Inadequately Controlled With Metformin
Human Patients
1698
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 1950

Prospective Prediction
Prediction Index
1950
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit as an oral therapy in HbA1c and weight reduction non-superior-non-inferior to semaglutide with numerically-inferior-to-semaglutide tolerability)
Technical Prediction
SUCCESS (statistically significant clinical benefit in HbA1c and weight reduction compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
171 days in advance
Readout Data Interpretation
orforglipron 36mg achieved 9.2% weight reduction; 2.2% A1C reduction; and 9.8% discontinuation rate at week 52; non-superior-non-inferior to 9.2% weight reduction; 2.0% A1C reduction; and est. 10% discontinuation rate at week 52 achieved by semaglutide oral 50mg (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (comparable efficacy and tolerability of orforglipron 36mg vs. oral semaglutide 50mg)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)
Phase
Phase 3
Status
Completed
Enrollment
1698
Lead sponsor
Eli Lilly and Company
Conditions
Type 2 Diabetes
Interventions
DRUG: Orforglipron; DRUG: Semaglutide
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-09-22
Primary completion
2025-08-22
Completion
2025-08-22
Results first posted
2026-09-15
Primary outcomes
  • Change From Baseline in Hemoglobin A1c (HbA1c) [Non-inferiority of 36 mg Orforglipron Versus 14 mg Semaglutide and 12 mg Orforglipron Versus 7 mg Semaglutide] (Baseline, Week 52)

NCT06045221 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials