Menu
Recruiting NCT07415954

A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

Phase II Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC0662-0419, Semaglutide, Placebo.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Croatia, Hungary, Japan, Poland +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study

Overview

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.

Interventions

  • Drug NNC0662-0419
    NNC0662-0419 will be administered subcutaneously.
  • Drug Semaglutide
    Semaglutide will be administered subcutaneously.
  • Drug Placebo
    Placebo will be administered subcutaneously.

Primary outcome measures

  • Change in glycated haemoglobin (HbA1c) (week 16) [Time frame: From baseline (week 0) to week 16]
  • Change in HbA1c (week 28) [Time frame: From baseline (week 0) to week 28]
  • Change in HbA1c (week 40) [Time frame: From baseline (week 0) to week 40]
Secondary outcome measures (12)
  • Relative change in body weight [Time frame: From baseline (week 0) to (week 40)]
  • Change in body weight [Time frame: From baseline (week 0) to (week 40)]
  • Change in HbA1c [Time frame: From baseline (week 0) to (week 16, 28 and 40)]
  • Change in Fasting Plasma Glucose (FPG) [Time frame: From baseline (week 0) to (week 16, 28 and 40)]
  • Change in Body Mass Index (BMI) [Time frame: From baseline (week 0) to (week 40)]
  • Change in waist circumference [Time frame: From baseline (week 0) to (week 40)]
  • Change in high sensitivity C-Reactive Protein (hsCRP) [Time frame: From baseline (week 0) to (week 40)]
  • Change in total cholesterol [Time frame: From baseline (week 0) to (week 40)]
  • Change in High-Density Lipoprotein (HDL) cholesterol [Time frame: From baseline (week 0) to (week 40)]
  • Change in Low-Density Lipoprotein (LDL) cholesterol [Time frame: From baseline (week 0) to (week 40)]
  • Change in triglycerides [Time frame: From baseline (week 0) to (week 40)]
  • Change in Urine Albumin Creatinine Ratio (UACR) [Time frame: From baseline (week 0) to (week 16, 28 and 40)]

Eligibility criteria

Inclusion criteria

  • Male or female (sex at birth).
  • Age 18-75 years (both inclusive) at the time of signing the informed consent.
  • Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as assessed by central laboratory at screening.
  • Willingness to obtain a high weight loss (greater than \[>\] 25% of weight at baseline).

Exclusion criteria

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. 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.

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 · 23 centers
  • First Valley Medical Group — Lancaster
  • Torrance Clinical Research Institute, Inc. — Lomita
  • Ark Clinical Research — Long Beach
  • Pacific Clinical Studies — Los Alamitos
  • Wetlin Research Associates, Inc. — San Diego
  • Diablo Clinical Research, Inc. — Walnut Creek
  • Encore Medical Research LLC — Hollywood
  • Bioclinical Research Alliance — Miami
  • … and 15 more centers
Spain · 6 centers
  • ABS La Roca CAP Vicenç_Endocrino — La Roca Del Vallés
  • Centro de Salud A Estrada — A Estrada
  • Equip D´Atencio Primaria Barcelona Sardenya — Barcelona
  • Hospital Vithas Sevilla — Castilleja de la Cuesta
  • Clínica Bofill — Girona
  • Centro de Saúde Concepción Arenal — Santiago de Compostela
Japan · 5 centers
  • Akaicho Clinic_Internal medicine — Chiba-shi, Chiba
  • Naka Kinen Clinic_Internal medicine — Ibaraki
  • Soka Sugiura Internal Medicine Clinic — Soka-shi, Saitama
  • Tokyo-Eki Center-building Clinic_Internal Medicine — Tokyo
  • ToCROM Clinic_Internal Medicine — Tokyo
Poland · 5 centers
  • "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik — Bialystok
  • Terpa Sp. z o.o. Sp. k. — Lublin
  • Formed 2 Sp. z o.o. — Oświęcim
  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA — Warsaw
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko — Zabrze
Thailand · 5 centers
  • Ramathibodi Hospital — Bangkok
  • Siriraj Hospital — Bangkok
  • Maharaj Nakorn Chiang Mai — Chiang Mai
  • Srinagarind Hospital — Khon Kaen
  • Maharat Nakhon Ratchasima Hospital — Nakhon Ratchasima
Croatia · 4 centers
  • Opca bolnica Karlovac — Karlovac
  • Poliklinika SLAVONIJA OSIJEK — Osijek
  • Opca bolnica Varazdin_Endocrinology — Varaždin
  • Poliklinika Solmed — Zagreb
Portugal · 4 centers
  • Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos — Coimbra
  • Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda — Ponte de Lima
  • Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos — Vila do Conde
  • Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia — Vila Nova de Gaia
Slovakia · 4 centers
  • DIADA, s.r.o. — Bardejov
  • Metabol KLINIK s.r.o. — Bratislava
  • Diacrin s. r. o. — Bratislava
  • SIN AZUCAR s.r.o. — Malacky
South Korea · 4 centers
  • Korea University Ansan Hospital_Endocrinology — Ansan-si
  • Pusan National University Yangsan Hospital — Yangsan
  • Nowon Eulji Medical Center, Eulji University_Endocrinology — Seoul
  • Kangbuk Samsung Hospital_Endocrinology — Seoul
Hungary · 3 centers
  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ — Szeged
  • Debreceni Egyetem — Debrecen
  • Debreceni Egyetem — Debrecen

Identifiers

NCT: NCT07415954 · NN9662-8160 · U1111-1324-0310 · 2025-523260-20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗