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

NCT07533175 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9490-8024U1111-1313-63252024-520441-23
• Study Type: interventional
• Target: 630
• Locations: 10 countries
• Sites: 74

Brief 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. 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.

Conditions

Diabetes Mellitus; Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in body weight

  Measured as percentage (%) of body weight.

  From baseline (week 0) to (week 84)

Secondary Outcomes (28)

• Change in waist circumference

  From baseline (week 0) to (week 84)

• Change in glycated haemoglobin (HbA1c)

  From baseline (week 0) to (week 84)

• Change in systolic blood pressure (SBP)

  From baseline (week 0) to (week 84)

• Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score

  From baseline (week 0) to (week 84)

• Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

  From baseline (week 0) to (week 84)

Study Arms (5)

NNC0487-0111 dose level 1

EXPERIMENTAL

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.

Drug: NNC0487-0111

NNC0487-0111 dose level 2

EXPERIMENTAL

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.

Drug: NNC0487-0111

NNC0487-0111 dose level 3

EXPERIMENTAL

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.

Drug: NNC0487-0111

NNC0487-0111 dose level 4

EXPERIMENTAL

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.

Drug: NNC0487-0111

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (matched to NNC0487-0111)

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

NNC0487-0111 dose level 1; NNC0487-0111 dose level 2; NNC0487-0111 dose level 3; NNC0487-0111 dose level 4

Placebo (matched to NNC0487-0111) DRUG

Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (74)

Univ of Alabama Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Headlands Research California, LLC

Escondido, California, 92025, United States

RECRUITING

Torrance Clinical Research Institute, Inc.

Lomita, California, 90717, United States

RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

RECRUITING

Northeast Research Institute

Fleming Island, Florida, 32003, United States

RECRUITING

Jacksonville Ctr Clin Res

Jacksonville, Florida, 32216, United States

RECRUITING

Florida Institute for Clinical Research, LLC

Orlando, Florida, 32825, United States

RECRUITING

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

RECRUITING

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

RECRUITING

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

RECRUITING

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

RECRUITING

M3 Wake Research Chattanooga

Chattanooga, Tennessee, 37421, United States

RECRUITING

UT Southwestern Medical Center - Lingvay

Dallas, Texas, 75390, United States

RECRUITING

PlanIt Research, PLLC

Houston, Texas, 77079, United States

RECRUITING

National Clin Res Inc.

Richmond, Virginia, 23294, United States

RECRUITING

MICA- Medicina e Investigación Cardiometabólica

Manuel Alberti, Buenos Aires, B1669, Argentina

NOT YET RECRUITING

Kynet Recoleta

Buenos Aires, C1119ACU, Argentina

RECRUITING

Centro médico privado Cemaic

Córdoba, X5008, Argentina

RECRUITING

CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

Santa Fe, S3000FSO, Argentina

RECRUITING

Cline Research Center

Curitiba, Paraná, 80030-480, Brazil

RECRUITING

PUCCAMP - Hospital e Maternidade Celso Pierro

Campinas, São Paulo, 13060-803, Brazil

RECRUITING

CPCLIN - Centro de Pesquisas Clínicas

São Paulo, São Paulo, 01228-200, Brazil

RECRUITING

Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

NOT YET RECRUITING

Opca bolnica Karlovac

Karlovac, 47000, Croatia

RECRUITING

Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

Krapinske Toplice, 49217, Croatia

RECRUITING

Specijalna bolnica Thalassotherapia

Opatija, 51 410, Croatia

RECRUITING

Poliklinika SLAVONIJA OSIJEK

Osijek, 31000, Croatia

RECRUITING

Opca bolnica Pula

Pula, 52100, Croatia

RECRUITING

Poliklinika za oftalmologiju optometriju i neurologiju Lux

Solin, 21210, Croatia

RECRUITING

Opca bolnica Varazdin_Endocrinology

Varaždin, 42 000, Croatia

RECRUITING

Poliklinika Solmed

Zagreb, 10000, Croatia

RECRUITING

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád, 6725, Hungary

NOT YET RECRUITING

DRC Kft.

Balatonfüred, 8230, Hungary

NOT YET RECRUITING

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032, Hungary

NOT YET RECRUITING

Semmelweis Egyetem

Budapest, 1083, Hungary

COMPLETED

PVN Kutató Kft.

Budapest, 1102, Hungary

NOT YET RECRUITING

Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés

Budapest, 1134, Hungary

NOT YET RECRUITING

Trantor 99 Bt

Budapest, H-1213, Hungary

NOT YET RECRUITING

Somogy Vármegyei Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary

NOT YET RECRUITING

Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete

Bologna, Emilia-Romagna, 40138, Italy

NOT YET RECRUITING

Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale

Rome, Lazio, 00161, Italy

NOT YET RECRUITING

Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia

Milan, Lombardy, 20159, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obesità e Metabolismo

Palermo, Sicily, 90127, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele Milano

Milan, 20132, Italy

NOT YET RECRUITING

Dip. di Medicina Interna Policlinico Universitario Palermo

Palermo, 90127, Italy

NOT YET RECRUITING

Centro de Investigacion Clinica Endocrinologica de Jalisco

Guadalajara, Jalisco, 44670, Mexico

NOT YET RECRUITING

Clinstile S.A. de C.V.

Col Roma Norte, Mexico City, 06700, Mexico

NOT YET RECRUITING

Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab

Distrito Federal, México, D.F., 14080, Mexico

NOT YET RECRUITING

Unidad Medica para la Salud Integral (UMSI)

San Nicolás de los Garza, Nuevo León, 66465, Mexico

NOT YET RECRUITING

Centro de Investigación Clinica de Oaxaca (CICLO)

Oaxaca City, Oaxaca, 68020, Mexico

NOT YET RECRUITING

Consultorio de Endocrinología y Pediatría

Puebla City, 72190, Mexico

NOT YET RECRUITING

S.C. Top Diabet Srl

Craiova, Dolj, 200515, Romania

RECRUITING

Poli Cardinal Med Srl

Reghin, Mureș County, 545300, Romania

RECRUITING

CMI Dr. Pletea Noemi SRL

Bacau, 600154, Romania

RECRUITING

SC Nutrilife SRL

Bucharest, 013764, Romania

RECRUITING

SC Clinica Diabnutrimed S.R.L.

Bucharest, 020359, Romania

RECRUITING

Diabet Med SRL

Bucharest, 050913, Romania

RECRUITING

Cmi Dr. Cojocaru Cristina

Constanța, 900512, Romania

RECRUITING

A&C Medical Prime S.R.L.

Craiova, 200692, Romania

NOT YET RECRUITING

Spital Judetean De Urgenta Satu Mare

Satu Mare, 440055, Romania

RECRUITING

DIA - KONTROL s.r.o.

Levice, 93401, Slovakia

RECRUITING

Narodny Endokrinologicky a diabetologicky ustav

Ľubochňa, 03491, Slovakia

RECRUITING

OLIVER - MED s.r.o.

Rimavská Sobota, 979 01, Slovakia

RECRUITING

Peter Farkas MD, s.r.o.

Šahy, 93601, Slovakia

RECRUITING

DEImedi, s. r. o.

Šurany, 942 01, Slovakia

RECRUITING

ARETEUS s.r.o.

Trebišov, 075 01, Slovakia

RECRUITING

ARETEUS s.r.o.

Trebišov, 075 01, Slovakia

NOT YET RECRUITING

Seoul National University Bundang Hospital_Endocrinology

Seoungnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Chonnam National University Hospital_Endocrinology

Gwangju, 61469, South Korea

RECRUITING

Kyunghee University Medical Center_Endocrinology

Seoul, 02447, South Korea

RECRUITING

Seoul National University Hospital_Endocrinology

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System_Endocrinology

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center_Endocrinology

Seoul, 05505, South Korea

RECRUITING

The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology

Seoul, 07345, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Overweight; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): August 7, 2028
• Study Completion (Estimated): August 7, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

ME (6); CR (8); KR (7); BR (4); AR (4); HU (8); SL (7); US (15); RO (9); IT (6)