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NCT06153758 (Danuglipron in Obesity): BVCT ex-ante prediction vs. reported outcome

On 15 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 14 Apr 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06153758
Drug Name
Danuglipron
Drug MoA
once-daily oral GLPR1 agonist
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Obesity
Human Patients
33
Sponsor
Pfizer
Phase
Phase 1

Prediction of , index 1755

Prospective Prediction
Prediction Index
1755
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient clinical benefit in muscle retention and cardio protection for healthy obese patients at least numerically superior to orforglipron/GSBR1290)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in weight reduction for healthy obese patients against placebo despite being at least numerically inferior to orforglipron/GSBR1290)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
242 days in advance
Readout Data Interpretation
danuglipron discontinued further development based on the totality of efficacy and toxicity information; thus at least inferior to orforglipron
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1, 4-Part, Open-Label, Randomized Study With A 5-Period, 4 Sequence, Crossover Design to Compare the Single Dose Pharmacokinetics Between Immediate and Modified Release Formulations of Danuglipron Administered Orally to Healthy Adult Participants
Phase
Phase 1
Status
Completed
Enrollment
33
Lead sponsor
Pfizer
Conditions
Healthy Participants; Healthy Subjects
Interventions
DRUG: Danuglipron
Design
Non randomized · Crossover · None
Primary purpose
Basic science
Start
2023-11-27
Primary completion
2024-09-30
Completion
2024-09-30
Primary outcomes
  • Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state (Predose to 48 hours post danuglipron administration)
  • Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state (Predose to 48 hours post danuglipron administration)
  • Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state (Predose to 48 hours post danuglipron administration)
  • Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state (Predose to 48 hours post danuglipron administration)
  • Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state (Predose to 48 hours post danuglipron administration)

NCT06153758 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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