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

Phase 2RecruitingNCT07415954

Novo Nordisk A/S270 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

270

Conditions

Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (63)

First Valley Medical Group

Lancaster, California, United States

RECRUITING

Torrance Clinical Research Institute, Inc.

Lomita, California, United States

RECRUITING

Ark Clinical Research

Long Beach, California, United States

RECRUITING

Pacific Clinical Studies

Los Alamitos, California, United States

Outcomes

Primary Outcomes

Change in glycated haemoglobin (HbA1c) (week 16)

Measured as percentage-point (%-point).

Time frame: From baseline (week 0) to week 16

Change in HbA1c (week 28)

Measured as %-point.

Time frame: From baseline (week 0) to week 28

Change in HbA1c (week 40)

Measured as %-point.

Time frame: From baseline (week 0) to week 40

Secondary Outcomes

Relative change in body weight

Measured as percentage (%).

Time frame: From baseline (week 0) to (week 40)

Change in body weight

Measured as kilogram (kg).

Time frame: From baseline (week 0) to (week 40)

Change in HbA1c

Measured as %-point.

Time frame: From baseline (week 0) to (week 16, 28 and 40)

Change in Fasting Plasma Glucose (FPG)

Measured as millimoles per litre (mmol/L).

Time frame: From baseline (week 0) to (week 16, 28 and 40)

Change in Body Mass Index (BMI)

Measured in kilograms per square metre (kg/m\^2).

Time frame: From baseline (week 0) to (week 40)

Change in waist circumference

Measured in centimetre (cm).

Time frame: From baseline (week 0) to (week 40)

Change in high sensitivity C-Reactive Protein (hsCRP)

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 40)

Change in total cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 40)

Change in High-Density Lipoprotein (HDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 40)

Change in Low-Density Lipoprotein (LDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 40)

Change in triglycerides

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 40)

Change in Urine Albumin Creatinine Ratio (UACR)

Measured as ratio to baseline.

Time frame: From baseline (week 0) to (week 16, 28 and 40)

Change in estimated Glomerular Filtration Rate (eGFR) (creatinine cystatin C-based Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] 2021)

Measured in millilitres per minute per 1.73 square metre (mL/min/1.73 m\^2).

Time frame: From baseline (week 0) to (week 40)

Number of adverse events

Measured as number of events.

Time frame: From baseline (week 0) to (week 48)

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

Overview

Conditions

Interventions

Eligibility

Locations (63)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts