Study S001360

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations With the DV3396 Pen-injector and With the PDS290 Pen-injector in Subjects With Overweight or Obesity

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT04012255
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: TERMINATED
Enrollment: 29
Start: 2019-07-15
Primary completion: 2019-08-30
Lead sponsor: Novo Nordisk A/S
Conditions: Overweight; Obesity
Interventions: DRUG:Semaglutide (administered by DV3396 pen); DRUG:Semaglutide (administered by PDS290 pen)
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1221-9644; REGISTRY:2018-003923-13; NIH:2018

Registered primary outcomes

AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg [0-168 hours (Day 141-148) after last 2.4 mg dose]
Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg [0-168 hours (Day 141-148) after last 2.4 mg dose]

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