Trial · Interventional
Active, not recruitingPhase 3Registry dataAMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Short name AMAZE 12
Overview
- Status
- Active, not recruiting
- Phase
- Phase 3
- Enrollment
- 606 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
12 countries
United States, Argentina, Australia, Belgium, Bulgaria, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom
- Start
- 21 Apr 2026
- Primary completion
- 6 Jun 2028 (estimated)
- Completion
- 4 Jul 2028 (estimated)
- First posted
- 31 Mar 2026
- Last update posted
- 11 Sept 2026
- Conditions
- Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
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. 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 (a 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
Arms2
Experimental
NNC0487-0111
Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo comparator
Placebo
Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 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 week 40 to week 92
Registry description
Measured as percentage (%) of body weight.
Secondary outcomes(20)
Relative change in body weight
Time frame · From week 0 to week 92
Registry description
Measured as % of body weight.
Change in waist circumference
Time frame · From week 40 to week 92
Registry description
Measured as centimetre (cm).
Change in systolic blood pressure (SBP)
Time frame · From week 40 to week 92
Registry description
Measured as millimeter 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 week 40 to week 92
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. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame · From week 40 to week 92
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, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.
Change in body weight
Time frame · From week 40 to week 92
Registry description
Measured as kilogram (kg).
Change in body mass index (BMI)
Time frame · From week 40 to week 92
Registry description
Measured as kilograms per square meter (kg/m\^2).
Change in body weight
Time frame · From week 0 to week 92
Registry description
Measured as kg.
Change in BMI
Time frame · From week 0 to week 92
Registry description
Measured as kg/m\^2.
Change in glycated haemoglobin (HbA1c)
Time frame · From week 40 to week 92
Registry description
Measured as % of HbA1c.
Change in fasting plasma glucose (FPG)
Time frame · From week 40 to week 92
Registry description
Measured as millimoles per liter (mmol/L).
Change in fasting insulin
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
Change in diastolic blood pressure (DBP)
Time frame · From week 40 to week 92
Registry description
Measured as mmHg.
Change in total cholesterol
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
Change in High-density lipoprotein (HDL) cholesterol
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
Change in Low-density lipoprotein (LDL) cholesterol
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
Change in Very low-density lipoprotein (VLDL) cholesterol
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
Change in non-HDL cholesterol
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
Change in triglycerides
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame · From week 40 to week 92
Registry description
Measured as ratio to baseline.
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
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