This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.
The study comprised a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants were administered MBL949 or placebo at 8 biweekly intervals starting on Day 1 and a 10-week follow-up period. Participants were to be enrolled to: * MBL949 Arm 1, MBL949 Arm 2 and placebo in a 1:1:1 ratio * MBL949 Arm 3, MBL949 Arm 4 and placebo in a 1:1:1 ratio * If MBL949 Arm 1 was tolerated, MBL949 Arm 5 was enrolled with a 2:1 ratio (MBL:placebo) within each stratum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Morehead City, North Carolina, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Dallas, Texas, United States
Frequency and Severity of Adverse Events
Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
Time frame: Baseline to Day 169
Change-from-baseline in Weight
Baseline weight is defined as the last weight measurement before dosing in kilograms
Time frame: Week 16
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