The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by chance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
333
Altasciences Clinical LA, Inc.
Cypress, California, United States
RECRUITINGAltasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States
NOT_YET_RECRUITINGAltasciences Clinical Company, Inc
Montreal, Quebec, Canada
NOT_YET_RECRUITINGPart A - Number of treatment emergent adverse events (TEAEs)
Measured as Number of events.
Time frame: From baseline (week 0) to end of study (week 33)
Part B - Relative change in body weight
Measured as percentage of body weight.
Time frame: From baseline (week 0) to end of treatment (week 28)
Part C- AUC; the area under the UBT251 plasma concentration time curve
Measured as hour\*nanomoles per liter (h\*nmol/L)
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 43)
Part A - Relative change in body weight
Measured as percentage of body weight.
Time frame: From baseline (week 0) to end of treatment (week 28)
Part A - Change in body weight
Measured as kilogram (kg).
Time frame: From baseline (week 0) to end of treatment (week 28)
Part A - AUC; the area under the UBT251 plasma concentration-time curve
Measured as h\*nmol/L
Time frame: From pre-dose on day 1 to end of study (week 33)
Part A - Cmax; the maximum plasma concentration of UBT251
Measured as nanomole per liter (nmol/L)
Time frame: From pre-dose on day 1 to end of study (week 33)
Part B - Change in body weight
Measured as kg.
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Time frame: From baseline (week 0) to end of treatment (week 28)
Part B - Change in waist circumference
Measured as centimetre (cm).
Time frame: From baseline (week 0) to end of treatment (week 28)
Part B - Number of TEAEs
Measured as number of events
Time frame: From baseline (week 0) to end of study (week 33)
Part C - Cmax; the maximum plasma concentration of UBT251
Measured as nmol/L
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 43)
Part C - Number of treatment-emergent adverse events (TEAEs)
Measured as number of events.
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 43)