LivingGLP1
Study S002622

A Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 Monotherapy and Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity and Overweight With or Without Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration
NCT06151964
Acronym
CONTEMPO
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1; PHASE2
Masking
TRIPLE
Status
ACTIVE_NOT_RECRUITING
Enrollment
166
Start
2023-09-29
Primary completion
2027-01-29
Lead sponsor
AstraZeneca
Conditions
Overweight and Obesity
Interventions
DRUG:AZD9550; DRUG:placebo; DRUG:AZD9550 and AZD6234
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
REGISTRY:2023-504215-32-00; NIH:2023

Registered primary outcomes

  • Number and percentage of participants with any AE, SAEs, AEs leading to discontinuation of study intervention, AEs with outcome of death, and AEs leading to withdrawal from study. [Day - 35 to Day 261]
  • Number and percentage of participants with clinically significant changes from baseline in Vital Sign Parameters. [Day - 35 to Day 261]
  • Number and percentage of participants with clinically significant changes in ECG parameters. [Day - 35 to Day 261]
  • Number and percentage of participants with clinically significant changes from baseline in Clinical Laboratory Parameters [Day - 35 to Day 261]
  • Area Under Concentration-Time Curve of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]
  • Maximum observed concentration of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]
  • Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]
  • Time to maximum observed concentration of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]
  • Apparent oral clearance of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]
  • Apparent volume of distribution of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]
  • Ratio for AUC of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]
  • Ratio for Cmax of AZD9550 following repeat weekly SC doses [Day 1 to Day 65]

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