A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Novo Nordisk A/S1,200 enrolled

Overview

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,200

Conditions

Overweight Obesity Type 2 Diabetes Mellitus

Interventions

CagrilintideDRUG

Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

SemaglutideDRUG

Semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Placebo cagrilintideDRUG

Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female * Age above or equal to 18 years at the time of signing informed consent * BMI greather than or equal to 27.0 kg/m\^2 * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label * Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening * HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening Exclusion Criteria: * Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness * Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Locations (179)

Outcomes

Primary Outcomes

Relative change in body weight

Measured in percentage (%).

Time frame: From baseline (week 0) to end of treatment (week 68)

Achievement of greater than or equal to (≥) 5% weight reduction

Count of participant.

Time frame: From baseline (week 0) to end of treatment (week 68)

Secondary Outcomes

Achievement of ≥ 20% weight reduction

Count of participant.

Time frame: From baseline (week 0) to end of treatment (week 68)

Relative change in body weight

Measured in %.

Time frame: From baseline (week 0) to week 20

Change in waist circumference

Measured in centimeter (cm).

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in Glycated Haemoglobin (HbA1c)

Measured in %-points.

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in Systolic Blood Pressure (SBP)

Measured in millimeter of mercury (mmHg).

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score

Measured in score points.

Time frame: From baseline (week 0) to end of treatment (week 68)

Data from ClinicalTrials.gov

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Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly

John Muir Physicians Network

Concord, California, United States

Headlands Research California, LLC

Escondido, California, United States

Providence Medical Foundation

Fullerton, California, United States

St. Jos Heritage Hlthcr_Fllrtn

Fullerton, California, United States

Diabetes/Lipid Mgmt & Res Ctr

Huntington Beach, California, United States

Clinical Trials Research

Lincoln, California, United States

Velocity Clin Res Los Angeles

Los Angeles, California, United States

Velocity Clin Res Wstlke

Los Angeles, California, United States

Desert Oasis Hlthcr Med Group

Palm Springs, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

...and 169 more locations

Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score

Measured in score points.

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in body weight

Measured in kilogram (kg).

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in body mass index (BMI)

Measured in kilogram per meter square (kg/m\^2).

Time frame: From baseline (week 0) to end of treatment (week 68)

Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40)

Count of participant.

Time frame: From baseline (week 0) to end of treatment (week 68)

Achievement of HbA1c less than or equal to (≤) 6.5%

Count of participant.

Time frame: At end of treatment (week 68)

Change in Fasting Plasma Glucose (mmol/L)

Measured in millimoles per liter (mmol/L).

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in Fasting Plasma Glucose (mg/dL)

Measured in milligram per deciliter (mg/dL)

Time frame: From baseline (week 0) to end of treatment (week 68)

Ratio to baseline in fasting serum insulin

Measured in ratio.

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in Diastolic Blood Pressure (DBP)

Measured in mmHg.

Time frame: From baseline (week 0) to end of treatment (week 68)

Ratio to baseline in C-reactive protein (CRP)

Measured in ratio.

Time frame: From baseline (week 0) to end of treatment (week 68)

Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids

Measured in ratio.

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score

IWQOL-Lite-CT is a 20-item clinical outcomes assessment (COA) instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. Score ranges for composite score (physical composite, psychosocial composite and physical function composite) and Total score is 0-100. Higher scores indicate better level of functioning.

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score

CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). Higher score represents a greater level of Craving Control.

Time frame: From baseline (week 0) to end of treatment (week 68)

Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

Count of participant.

Time frame: From baseline (week 0) to end of treatment (week 68)

Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score

Count of participant.

Time frame: From baseline (week 0) to end of treatment (week 68)

Change in IWQOL-Lite-CT Physical Function score

Time frame: From baseline (week 0) to end of treatment (week 68)

Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup

Count of participant.

Time frame: From baseline (week 0) to end of treatment (week 68)

Continuous glucose monitoring: Change in mean glucose (mmol/L)

Measured in mmol/L.

Time frame: From baseline (week 0) to end of treatment (week 68)

Continuous glucose monitoring: Change in mean glucose (mg/L)

Measured in mg/L.

Time frame: From baseline (week 0) to end of treatment (week 68)

CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)

Measured in %-points.

Time frame: From baseline (week 0) to end of treatment (week 68)

CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)

Measured in %-points.

Time frame: From baseline (week 0) to end of treatment (week 68)

CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL)

Measured in %-points.

Time frame: From baseline (week 0) to end of treatment (week 68)

CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL)

Measured in %-points.

Time frame: From baseline (week 0) to end of treatment (week 68)

CGM: Within-day glycaemic variability (% CV)

Measured in %.

Time frame: At end of treatment (week 68)

Number of Treatment Emergent Adverse Events (TEAEs)

Count of events.

Time frame: From baseline (week 0) to end of study (week 75)

Number of Treatment Emergent Serious adverse events (TESAEs)

Count of events.

Time frame: From baseline (week 0) to end of study (week 75)

Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)

Count of episodes.

Time frame: From baseline (week 0) to end of study (week 75)

Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Count of episodes.

Time frame: From baseline (week 0) to end of study (week 75)