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AMAZE 8NCT07400107

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

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 10 words Show 6 more changesShow less
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study completion moved earlier from Jan 26, 2029 to Dec 19, 2028
    • Enrollment target: estimated 1000 to confirmed 985
    • Study sites: 120 to 122
    • Primary completion date: Dec 12, 2028 to Dec 19, 2028
    • Secondary endpoints: details revised at 7 of 24 entries
  2. Study sites: 119 to 120v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Relative change in body weight
Timeframe: From baseline (week 0) to week 84

Secondary (24)

Change in waist circumference
Change in systolic blood pressure (SBP)
Change in body weight
Change in body mass index (BMI)
Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)
Show 19 moreShow less
Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)
Number of participants with achievement of HbA1c < 5.7% (yes/no)
Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)
Change in FPG measured as milligrams per deciliter (mg/dL)
Ratio to baseline: change in fasting insulin
Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)
Change in diastolic blood pressure (DBP)
Ratio to baseline: change in total cholesterol
Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Ratio to baseline: change in non-HDL cholesterol
Ratio to baseline: change in triglycerides
Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Number of Treatment Emergent Adverse Events (TEAEs)
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Number of TEAEs leading to permanent treatment discontinuation
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)
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

Arms and interventions

NNC0487-0111Experimental

Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

SemaglutideActive comparator

Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Drugs: NNC0487-0111, Semaglutide, Placebo (matched to NNC0487-0111), Placebo (matched to semaglutide)

Sites

122 sites in 14 countries

India 20, Poland 20, Bulgaria 11, Germany 10, United States 10, Croatia 8, Portugal 8, Romania 8, Turkey (Türkiye) 7, Hungary 5, Thailand 5, Brazil 4, Argentina 3, Mexico 3