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NCT06109311 (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 15 Oct 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT06109311
Acronym
ACHIEVE-5
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 titrated insulin glargine; with or without metformin and/or SGLT-2 inhibitors
Human Patients
546
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 1952

Prospective Prediction
Prediction Index
1952
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit as an oral therapy in HbA1c and weight reduction non-superior-non-inferior to semaglutide/GSBR1290 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
199 days in advance
Readout Data Interpretation
orforglipron 36mg achieved 1.1% placebo-adjusted A1C reduction at week 40
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
Phase
Phase 3
Status
Completed
Enrollment
546
Lead sponsor
Eli Lilly and Company
Conditions
Type 2 Diabetes
Interventions
DRUG: Orforglipron; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-11-10
Primary completion
2025-09-15
Completion
2025-09-15
Primary outcomes
  • Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 40)

NCT06109311 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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