Study S000041

Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With 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 Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04969939
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 120
Start: 2021-07-15
Primary completion: 2022-12-06
Lead sponsor: Novo Nordisk A/S
Conditions: Obesity
Interventions: DRUG:Semaglutide 2.4 mg and NNC0165-1875 2.0 mg; DRUG:Semaglutide 2.4 mg and placebo 2.0 mg; DRUG:Semaglutide 2.4 mg and NNC0165-1875 1.0 mg; DRUG:Semaglutide 2.4 mg and placebo 1.0 mg
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1254-9046

Registered primary outcomes

Part 1: Number of Treatment-emergent Adverse Events (TEAEs) [Part 1: From time of dosing (day 1) to follow-up (week 24)]
Part 2b: Percentage Change in Body Weight [Part 2: Randomisation (week 32), end of treatment (week 48)]

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