AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Phase 3RecruitingNCT07533175

Novo Nordisk A/S630 enrolled

Overview

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

630

Conditions

Diabetes Mellitus Overweight Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before screening. * Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) 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) before screening. * Haemoglobin A1c (HbA1c) 7-10% \[53-86 (millimoles per mole) mmol/mol\] (both inclusive) as measured by the central laboratory at screening. Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter per minute per meter square (mL/min/1.73 m\^2) \[2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\], at screening. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening. Diabetic retinopathy or maculopathy must be verified by an eye 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. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.

Locations (74)

Univ of Alabama Birmingham

Birmingham, Alabama, United States

RECRUITING

Headlands Research California, LLC

Escondido, California, United States

COMPLETED

Torrance Clinical Research Institute, Inc.

Lomita, California, United States

RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Outcomes

Primary Outcomes

Relative change in body weight

Measured as percentage (%) of body weight.

Time frame: From baseline (week 0) to (week 84)

Secondary Outcomes

Change in waist circumference

Measured as centimetre (cm).

Time frame: From baseline (week 0) to (week 84)

Change in glycated haemoglobin (HbA1c)

Measured as percentage (%) of HbA1c.

Time frame: From baseline (week 0) to (week 84)

Change in systolic blood pressure (SBP)

Measured as millimetre of mercury (mmHg).

Time frame: From baseline (week 0) to (week 84)

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 functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.

Time frame: From baseline (week 0) to (week 84)

Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning 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 (SD) of 10. The physical functioning ranges from 19.0 to 57.6. Higher scores indicate better functional health and well-being.

Time frame: From baseline (week 0) to (week 84)

Change in body weight

Measured as kilogram (kg).

Time frame: From baseline (week 0) to (week 84)

Change in body mass index (BMI)

Measured as kilograms per meter squared (kg/m\^2).

Time frame: From baseline (week 0) to (week 84)

Change in IWQOL-Lite-CT: Physical, Psychosocial, 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. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.

Time frame: From baseline (week 0) to (week 84)

Achievement of HbA1c < 7.0% (Yes/No)

Measured as number of participants

Time frame: From baseline (week 0) to (week 84)

Achievement of HbA1c ≤ 6.5% (Yes/No)

Measured as number of participants

Time frame: From baseline (week 0) to (week 84)

Achievement of HbA1c < 5.7% (Yes/No)

Measured as number of participants

Time frame: From baseline (week 0) to (week 84)

Change in fasting plasma glucose (FPG) (mmol/L)

Measured as millimoles per liter (mmol/L)

Time frame: From baseline (week 0) to (week 84)

Change in fasting plasma glucose (FPG) (mg/dL)

Measured as milligram per deciliter (mg/dL)

Time frame: From baseline (week 0) to (week 84)

Change in fasting insulin

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Change in urinary albumin-to-creatinine ratio (UACR)

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Change in diastolic blood pressure

Measured as mmHg.

Time frame: From baseline (week 0) to (week 84)

Change in high-sensitivity C-reactive protein (hsCRP)

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Number of Treatment Emergent Adverse Events (TEAEs)

Measured as count of events.

Time frame: From baseline (week 0) to week 88

Number of Treatment Emergent Serious Adverse Events (TESAEs)

Measured as count of events.

Time frame: From baseline (week 0) to week 88

Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation

Measured as count of events.

Time frame: From baseline (week 0) to week 88

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

Measured as number of episodes

Time frame: From baseline (week 0) to week 88

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

Measured as number of episodes

Time frame: From baseline (week 0) to week 88

Change in Total cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Change in High-density lipoprotein (HDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Change in Low-density lipoprotein (LDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Change in Very low-density lipoprotein (VLDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Change in Non-HDL cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

Change in Triglycerides

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 84)

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Overview

Conditions

Interventions

Eligibility

Locations (74)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts