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
- Summary
- 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.
- Acronym
- AMAZE 8
- Short title
- 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
- Official title
- Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2029-01-26
- First posted
- 2026-02-10
- Registry last updated
- 2026-03-12
- Primary completion date
- 2028-12-12
- Start date
- 2026-05-20
- Participants
- 1,000
- Participant count basis
- Estimated
- Planned participants
- 1,000
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07400107
- ClinicalTrials.gov ID
- NCT07400107
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Relative change in body weight
Timeframe: From baseline (week 0) to week 84
Measured as percentage of body weight.
Change in waist circumference
Timeframe: From baseline (week 0) to week 84
Measured as centimeter (cm).
Change in systolic blood pressure (SBP)
Timeframe: From baseline (week 0) to week 84
Measured as millimeter of mercury (mmHg).
Change in body weight
Timeframe: From baseline (week 0) to week 84 and week 104
Measured as kilograms (kg).
Change in body mass index (BMI)
Timeframe: From baseline (week 0) to week 84 and week 104
Measured as kilograms per meter squared (kg/m\^2).
Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)
Timeframe: From baseline (week 0) to week 84
Measured as count of participants.
Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)
Timeframe: From baseline (week 0) to week 84
Measured as count of participants.
Number of participants with achievement of HbA1c < 5.7% (yes/no)
Timeframe: From baseline (week 0) to week 84
Measured as count of participants.
Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)
Timeframe: From baseline (week 0) to week 84
Measured as mmol/L.
Change in FPG measured as milligrams per deciliter (mg/dL)
Timeframe: From baseline (week 0) to week 84
Measured as mg/dL.
Ratio to baseline: change in fasting insulin
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Change in diastolic blood pressure (DBP)
Timeframe: From baseline (week 0) to week 84
Measured as mmHg.
Ratio to baseline: change in total cholesterol
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Ratio to baseline: change in non-HDL cholesterol
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Ratio to baseline: change in triglycerides
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Timeframe: From baseline (week 0) to week 84
Measured as ratio.
Number of Treatment Emergent Adverse Events (TEAEs)
Timeframe: From baseline (week 0) to week 84 and week 109
Measured as events.
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Timeframe: From baseline (week 0) to week 84 and week 109
Measured as events.
Number of TEAEs leading to permanent treatment discontinuation
Timeframe: From baseline (week 0) to week 84 and week 109
Measured as events.
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)
Timeframe: From baseline (week 0) to week 84 and week 109
Measured as episodes.
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
Timeframe: From baseline (week 0) to week 84 and week 109
Measured as episodes.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
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.
- Encore Medical Research LLCHollywood, United States
- Optimal Research SitesOrange City, United States
- Encore Medical Research of WestonWeston, United States
- Endocrine Research Solutions, IncRoswell, United States
- Elite Clinical TrialsBlackfoot, United States
- Endo And Metab ConsRockville, United States
- Arcturus Healthcare, PLC.Troy, United States
- Velocity Clin Res, DallasDallas, United States
- Consano Clinical Research, LLCShavano Park, United States
- Selma Medical AssociatesWinchester, United States
- Centro de Investigaciones MetabólicasCapital Federal, Argentina
- Centro Médico CIMELLanús Este, Argentina
- Centro Médico Privado San Vicente DiabetesCórdoba, Argentina
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.Porto Alegre, Brazil
- i9 Pesquisas ClínicasCampinas, Brazil
- CPQuali Pesquisa Clínica LtdaSão Paulo, Brazil
- BR Trials - Ensaios Clínicos e Consultoria Ltda.São Paulo, Brazil
- Gotse Delchev, Bulgaria
- Medical centre Zdrave 1 OODKozloduy, Bulgaria
- UMHAT Pulmed OOD - Pazardzhik, Department of Internal DiseasesPazardzhik, Bulgaria
- MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic DiseasesPleven, Bulgaria
- DCC I- Pleven EOOD EndocrinologyPleven, Bulgaria
- MHAT Knyaginya Klementina - Sofia EADSofia, Bulgaria
- MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseasesSofia, Bulgaria
- Acibadem City Clinic UMHAT Tokuda EAD, EndocrinologySofia, Bulgaria
And 95 more, listed on the interactive page.
- 2024-520446-31
- U1111-1313-8017
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Obesity disorder Primary condition
- Type 2 diabetes mellitus