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NCT05613387 (ZP8396 in Obesity): BVCT ex-ante prediction vs. reported outcome

On 6 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 20 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05613387
Drug Name
ZP8396
Drug MoA
long-lasting amylin analog
Drug Modality
peptide biologic
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Obesity
Human Patients
68
Sponsor
Zealand Pharma
Phase
Phase 1

Prediction of , index 1498

Prospective Prediction
Prediction Index
1498
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit for repeated-dose ZP8396; which is inferior to semaglutide with increasing toxicity for elderly obese population with comorbidities)
Technical Prediction
SUCCESS (statistically significant clinical benefit in weight loss)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
106 days in advance
Readout Data Interpretation
6.9% weight loss in 16 weeks among male adults with 49 years old vs 13.1% weight loss in 12 weeks by Amycretin.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
Phase
Phase 1
Status
Completed
Enrollment
68
Lead sponsor
Zealand Pharma
Conditions
Overweight; Healthy Volunteers; Obese
Interventions
DRUG: ZP8396; DRUG: Drug: Placebo (ZP8396)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-11-07
Primary completion
2024-06-13
Completion
2024-06-13
Primary outcomes
  • Incidence of treatment emergent adverse events (TEAEs) (Part 1: From dosing (Day 1) to end of trial (Day 92); Part 2: From dosing (Day 1) to end of trial (Day 169 for Cohort 1 and 2, Day 176 for Cohort 3))

NCT05613387 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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