Study S001178

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 133 in Subjects With Obesity

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04478708
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 110
Start: 2020-08-07
Primary completion: 2022-11-18
Lead sponsor: Amgen
Conditions: Obesity
Interventions: BIOLOGICAL:maridebart cafraglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES

Registered primary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0006305	A GIPR antagonist conjugated to GLP-1 analogues promotes weight loss with improved metabolic parameters in preclinical and phase 1 settings. Véniant MM, Nature metabolism	2024	Randomized trial	PMID 38316982 DOI	cites ClinicalTrials.gov:NCT04478708; registry reference BACKGROUND:38316982