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

Official title

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)

Overview

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.

Interventions

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

Primary outcome measures

• Relative change in body weight [Time frame: From baseline (week 0) to (week 84)]

Secondary outcome measures (12)

• Change in waist circumference [Time frame: From baseline (week 0) to (week 84)]
• Change in glycated haemoglobin (HbA1c) [Time frame: From baseline (week 0) to (week 84)]
• Change in systolic blood pressure (SBP) [Time frame: 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 [Time frame: From baseline (week 0) to (week 84)]
• Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score [Time frame: From baseline (week 0) to (week 84)]
• Change in body weight [Time frame: From baseline (week 0) to (week 84)]
• Change in body mass index (BMI) [Time frame: From baseline (week 0) to (week 84)]
• Change in IWQOL-Lite-CT: Physical, Psychosocial, Total score [Time frame: From baseline (week 0) to (week 84)]
• Achievement of HbA1c < 7.0% (Yes/No) [Time frame: From baseline (week 0) to (week 84)]
• Achievement of HbA1c ≤ 6.5% (Yes/No) [Time frame: From baseline (week 0) to (week 84)]
• Achievement of HbA1c < 5.7% (Yes/No) [Time frame: From baseline (week 0) to (week 84)]
• Change in fasting plasma glucose (FPG) (mmol/L) [Time frame: From baseline (week 0) to (week 84)]

Eligibility criteria

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 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 15 centers

• Univ of Alabama Birmingham — Birmingham
• Headlands Research California, LLC — Escondido
• Torrance Clinical Research Institute, Inc. — Lomita
• Diablo Clinical Research, Inc. — Walnut Creek
• Northeast Research Institute — Fleming Island
• Jacksonville Ctr Clin Res — Jacksonville
• Florida Institute for Clinical Research, LLC — Orlando
• Oviedo Medical Research, LLC — Oviedo
• … and 7 more centers

Romania · 9 centers

• S.C. Top Diabet Srl — Craiova
• Poli Cardinal Med Srl — Reghin
• CMI Dr. Pletea Noemi SRL — Bacau
• SC Nutrilife SRL — Bucharest
• SC Clinica Diabnutrimed S.R.L. — Bucharest
• Diabet Med SRL — Bucharest
• Cmi Dr. Cojocaru Cristina — Constanța
• A&C Medical Prime S.R.L. — Craiova
• … and 1 more center

Croatia · 8 centers

• Opca bolnica Karlovac — Karlovac
• Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology — Krapinske Toplice
• Specijalna bolnica Thalassotherapia — Opatija
• Poliklinika SLAVONIJA OSIJEK — Osijek
• Opca bolnica Pula — Pula
• Poliklinika za oftalmologiju optometriju i neurologiju Lux — Solin
• Opca bolnica Varazdin_Endocrinology — Varaždin
• Poliklinika Solmed — Zagreb

Hungary · 8 centers

• Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ — Szeged
• DRC Kft. — Balatonfüred
• Szent Margit Rendelőintézet Nonprofit Kft. — Budapest
• Semmelweis Egyetem — Budapest
• PVN Kutató Kft. — Budapest
• Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés — Budapest
• Trantor 99 Bt — Budapest
• Somogy Vármegyei Kaposi Mór Oktató Kórház — Kaposvár

Slovakia · 7 centers

• DIA - KONTROL s.r.o. — Levice
• Narodny Endokrinologicky a diabetologicky ustav — Ľubochňa
• OLIVER - MED s.r.o. — Rimavská Sobota
• Peter Farkas MD, s.r.o. — Šahy
• DEImedi, s. r. o. — Šurany
• ARETEUS s.r.o. — Trebišov
• ARETEUS s.r.o. — Trebišov

South Korea · 7 centers

• Seoul National University Bundang Hospital_Endocrinology — Seoungnam-si
• Chonnam National University Hospital_Endocrinology — Gwangju
• Kyunghee University Medical Center_Endocrinology — Seoul
• Seoul National University Hospital_Endocrinology — Seoul
• Severance Hospital, Yonsei University Health System_Endocrinology — Seoul
• Asan Medical Center_Endocrinology — Seoul
• The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology — Seoul

Italy · 6 centers

• Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e pre — Bologna
• Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale — Rome
• Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetolo — Milan
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obe — Palermo
• IRCCS Ospedale San Raffaele Milano — Milan
• Dip. di Medicina Interna Policlinico Universitario Palermo — Palermo

Mexico · 6 centers

• Centro de Investigacion Clinica Endocrinologica de Jalisco — Guadalajara
• Clinstile S.A. de C.V. — Col Roma Norte
• Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab — Distrito Federal
• Unidad Medica para la Salud Integral (UMSI) — San Nicolás de los Garza
• Centro de Investigación Clinica de Oaxaca (CICLO) — Oaxaca City
• Consultorio de Endocrinología y Pediatría — Puebla City

Argentina · 4 centers

• MICA- Medicina e Investigación Cardiometabólica — Manuel Alberti
• Kynet Recoleta — Buenos Aires
• Centro médico privado Cemaic — Córdoba
• CEDIR - Centro de diagnóstico y rehabilitación Santa Fe — Santa Fe

Brazil · 4 centers

• Cline Research Center — Curitiba
• PUCCAMP - Hospital e Maternidade Celso Pierro — Campinas
• CPCLIN - Centro de Pesquisas Clínicas — São Paulo
• Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo

Identifiers

NCT: NCT07533175 · NN9490-8024 · U1111-1313-6325 · 2024-520441-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗