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Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520440-42-00
Enrollment
210
Registered
2026-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

Relative change in body weight

Detailed description

CCI, CCI, CCI, Change in waist circumference, Change in systolic blood pressure (SBP), Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score, CCI, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea, CCI, Change in body weight, Change in body mass index (BMI), CCI, Change in IWQOL-Lite-CT Physical composite score Psychosocial composite score Total score, CCI, CCI, CCI, Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Change in fasting insulin, Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), CCI, CCI, Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation, Extension phase secondary endpoints are as follows: Relative change in body weight, CCI, Change in body weight, Change in body mass index (BMI), CCI, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score, Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT): Physical composite score Physical functioning score Psychosocial composite score Total score, CCI, CCI, CCI, CCI, Change in waist circumference, Change in systolic blood pressure (SBP), Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Change in fasting insulin, Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglyceride, Change in high-sensitivity C-reactive protein (hsCRP), CCI, CCI, Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation

Interventions

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Relative change in body weight

Secondary

MeasureTime frame
CCI, CCI, CCI, Change in waist circumference, Change in systolic blood pressure (SBP), Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score, CCI, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea, CCI, Change in body weight, Change in body mass index (BMI), CCI, Change in IWQOL-Lite-CT Physical composite score Psychosocial composite score Total score, CCI, CCI, CCI, Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Change in fasting insulin, Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), CCI, CCI, Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading

Outcome results

None listed

Source: EU CTIS · Data processed: May 6, 2026