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NCT06555822 (AZD5004 in Obesity): BVCT ex-ante prediction vs. reported outcome

On 19 Aug 2024, BioinvestGPT's BVCT predicted technical partial failure and commercial partial success for this trial. The 5 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably insufficient.

Clinical Trial

NCTID
NCT06555822
Drug Name
AZD5004
Drug MoA
GLP1R agonist
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Obesity
Human Patients
15
Sponsor
AstraZeneca
Phase
Phase 1

Prediction of , index 1759

Prospective Prediction
Prediction Index
1759
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 FAILURE (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
78 days in advance
Readout Data Interpretation
AZD5004 achieved 5.8% weight reduction in more than four weeks (no placebo arm data); thus inferior to VK2735's 6.8% weight reduction at day 28 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase I, Two-Part Study in Healthy Volunteers Consisting of a Randomized, Single-blind, Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5004 and a Randomized, Open-Label, Two-way Cross-over Study to Compare the Relative Bioavailability of Two Oral Tablet Strengths of AZD5004
Phase
Phase 1
Status
Completed
Enrollment
31
Lead sponsor
AstraZeneca
Conditions
Healthy Participants
Interventions
DRUG: AZD5004; DRUG: Placebo
Design
Randomized · Parallel · Single
Primary purpose
Treatment
Start
2024-08-15
Primary completion
2025-03-06
Completion
2025-03-06
Primary outcomes
  • Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (From screening (Day -28) to last follow up visit (Day 120))
  • Part B: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004 (From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2))
  • Part B: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast) (From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2))
  • Part B: Area under concentration-time curve from time 0 to infinity (AUCinf) (From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2))
  • Part B: Time to reach maximum observed concentration (tmax) (From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2))

NCT06555822 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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