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

Short name AMAZE 2

NCTNCT07533175Other idNN9490-8024Other idU1111-1313-6325Other id2024-520441-23

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 630 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 10 countries
United States, Argentina, Brazil, Croatia, Hungary, Italy, Mexico, Romania, Slovakia, South Korea
Start: 13 Apr 2026
Primary completion: 7 Aug 2028 (estimated)
Completion: 7 Aug 2028 (estimated)
First posted: 16 Apr 2026
Last update posted: 30 Sept 2026
Conditions: Diabetes Mellitus · Overweight · Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 3
AMAZE 2
NCT07533175
13 Apr 2026 to est. 7 Aug 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

NNC0487-0111Drug
Placebo (matched to NNC0487-0111)Drug

Arms5

Experimental
NNC0487-0111 dose level 1
Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental
NNC0487-0111 dose level 2
Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental
NNC0487-0111 dose level 3
Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental
NNC0487-0111 dose level 4
Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo comparator
Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Primary outcomes1

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as percentage (%) of body weight.

Secondary outcomes(20)

Change in waist circumference
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as centimetre (cm).
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as percentage (%) of HbA1c.
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as millimetre of mercury (mmHg).
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
Time frame · From baseline (week 0) to (week 84)
Registry description
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.
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame · From baseline (week 0) to (week 84)
Registry description
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.
Change in body weight
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as kilogram (kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as kilograms per meter squared (kg/m\^2).
Change in IWQOL-Lite-CT: Physical, Psychosocial, Total score
Time frame · From baseline (week 0) to (week 84)
Registry description
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.
Achievement of HbA1c < 7.0% (Yes/No)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as number of participants
Achievement of HbA1c ≤ 6.5% (Yes/No)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as number of participants
Achievement of HbA1c < 5.7% (Yes/No)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as number of participants
Change in fasting plasma glucose (FPG) (mmol/L)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as millimoles per liter (mmol/L)
Change in fasting plasma glucose (FPG) (mg/dL)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as milligram per deciliter (mg/dL)
Change in fasting insulin
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as ratio to baseline.
Change in urinary albumin-to-creatinine ratio (UACR)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as ratio to baseline.
Change in diastolic blood pressure
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as mmHg.
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame · From baseline (week 0) to (week 84)
Registry description
Measured as ratio to baseline.
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame · From baseline (week 0) to week 88
Registry description
Measured as count of events.
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Time frame · From baseline (week 0) to week 88
Registry description
Measured as count of events.
Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation
Time frame · From baseline (week 0) to week 88
Registry description
Measured as count of events.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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