AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Phase 3Not Yet RecruitingNCT07400107

Novo Nordisk A/S1,000 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. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,000

Conditions

Obesity Overweight Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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 ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at 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. Key Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 milliliter (mL)/ minute (min)/1.73 meter squared (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) within 180 days before screening or are expected to require treatment within 180 days 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 randomization. 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 (120)

Encore Medical Research LLC

Hollywood, Florida, United States

Optimal Research Sites

Orange City, Florida, United States

Encore Medical Research of Weston

Weston, Florida, United States

Endocrine Research Solutions, Inc

Roswell, Georgia, United States

Elite Clinical Trials

Blackfoot, Idaho, 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 centimeter (cm).

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

Change in systolic blood pressure (SBP)

Measured as millimeter of mercury (mmHg).

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

Change in body weight

Measured as kilograms (kg).

Time frame: From baseline (week 0) to week 84 and week 104

Change in body mass index (BMI)

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

Time frame: From baseline (week 0) to week 84 and week 104

Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)

Measured as count of participants.

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

Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)

Measured as count of participants.

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

Number of participants with achievement of HbA1c < 5.7% (yes/no)

Measured as count of participants.

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

Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)

Measured as mmol/L.

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

Change in FPG measured as milligrams per deciliter (mg/dL)

Measured as mg/dL.

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

Ratio to baseline: change in fasting insulin

Measured as ratio.

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

Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)

Measured as ratio.

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

Change in diastolic blood pressure (DBP)

Measured as mmHg.

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

Ratio to baseline: change in total cholesterol

Measured as ratio.

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

Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol

Measured as ratio.

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

Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol

Measured as ratio.

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

Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol

Measured as ratio.

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

Ratio to baseline: change in non-HDL cholesterol

Measured as ratio.

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

Ratio to baseline: change in triglycerides

Measured as ratio.

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

Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)

Measured as ratio.

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

Number of Treatment Emergent Adverse Events (TEAEs)

Measured as events.

Time frame: From baseline (week 0) to week 84 and week 109

Number of Treatment Emergent Serious Adverse Events (TESAEs)

Measured as events.

Time frame: From baseline (week 0) to week 84 and week 109

Number of TEAEs leading to permanent treatment discontinuation

Measured as events.

Time frame: From baseline (week 0) to week 84 and week 109

Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 millimole per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by a blood glucose (BG) meter)

Measured as episodes.

Time frame: From baseline (week 0) to week 84 and week 109

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 episodes.

Time frame: From baseline (week 0) to week 84 and week 109

AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Overview

Conditions

Interventions

Eligibility

Locations (120)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts