This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Univ of Alabama_Birmingham
Birmingham, Alabama, United States
RECRUITINGChambliss Clinical Trials, LLC
Montgomery, Alabama, United States
RECRUITINGElite Clinical Network - Tucson
Tucson, Arizona, United States
RECRUITINGScripps Whittier Diabetes Inst
La Jolla, California, United States
Relative change in body weight
Measured as percentage (%) of body weight.
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of greater than or equals (>=) 5% body weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of >= 10% body weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of >= 15% body weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in waist circumference
Measured as centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in lipids: triglycerides
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in high sensitivity C-reactive protein (hsCRP)
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT) physical function score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in body weight
Measured as kilogram (kg).
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in SF-36v2® health survey acute (SF-36v2® acute) physical component summary score
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in SF-36v2® mental component summary score
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in IWQOL-Lite-CT total score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT physical function score (yes/no)
Measured as count of participants. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in systolic blood pressure (SBP)
Measured as millimeter of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in lipids: total cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in lipids: non-HDL cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in lipids: free fatty acids
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in glycated haemoglobin (HbA1c) in percentage-points (%-points)
Measured as %-points.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in HbA1c in millimole per mole (mmol/mol)
Measured as mmol/mol.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L)
Measured as mmol/L.
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in FPG in milligram per deciliter (mg/dL)
Measured as mg/dL.
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in fasting serum insulin
Measured as ratio.
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of treatment emergent adverse events
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 71)
Number of treatment emergent serious adverse events (TESAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 71)
Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 71)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 71)
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