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NCT05669599 (MariTide in Obesity Overweight Type 2 Diabetes Mellitus): BVCT ex-ante prediction vs. reported outcome

On 3 Feb 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 26 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (weight loss) and commercially insufficient (inferior to tirzepatide/semaglutide tolerability).

Clinical Trial

NCTID
NCT05669599
Drug Name
MariTide (AMG133)
Drug MoA
antibody-peptide conjugate that activates GLP1R via peptide and inhibits GIPR via antibody
Drug Modality
antibody fragment biologic
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Obesity Overweight Type 2 Diabetes Mellitus
Human Patients
592
Sponsor
Amgen
Phase
Phase 2

Prediction of , index 1442

Prospective Prediction
Prediction Index
1442
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit due to inferior-to-tirzepatide/semaglutide long-term detrimental toxicity for both nondiabetic and diabetic patients; despite superior-to-tirzepatide/semaglutide efficacy in morbid weight loss)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in weight loss) partial FAILURE (statistically insignificant clinical benefit in HbA1c reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
297 days in advance
Readout Data Interpretation
MariTide achieved 20% weight loss with 11% TEAE-related discontinuation for obese nondiabetic patients; numerically superior to the tirzepatide's 19.5% weight loss yet inferior to tirzepatide 6.2% TEAE-related discontinuation for obese nondiabetic patients at week 52 (10.1056/NEJMoa2206038); superior to the semaglutide's 13.4% weight loss yet inferior to semaglutide's 5-8% TEAE-related discontinuation for obese nondiabetic patients at week 52 (see add link for semaglutide's data on Lancet)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (weight loss) and commercially insufficient (inferior to tirzepatide/semaglutide tolerability)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
Phase
Phase 2
Status
Completed
Enrollment
592
Lead sponsor
Amgen
Conditions
Obesity; Overweight; Type 2 Diabetes Mellitus
Interventions
BIOLOGICAL: Maridebart Cafraglutide; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-01-18
Primary completion
2024-10-08
Completion
2025-12-16
Primary outcomes
  • Percent Change From Baseline to Week 52 in Body Weight (Baseline and Week 52)

NCT05669599 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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