A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

Novo Nordisk A/S355 enrolled

Overview

This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

355

Conditions

Obesity

Interventions

NNC0519-0130DRUG

NNC0519-0130 will be administered subcutaneously.

PlaceboDRUG

Placebo will be administered subcutaneously.

TirzepatideDRUG

Tirzepatide will be administered subcutaneously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female of non-childbearing potential, or male. a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male. * Age 18-75 years (both inclusive) at the time of signing the informed consent. * History of at least one self-reported unsuccessful dietary effort to lose body weight. * a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. * b) BMI ≥ 30.0 kg/m2. Exclusion Criteria: * HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus. * Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.

Locations (51)

Outcomes

Primary Outcomes

Relative change in body weight

Measured in percentage of body weight.

Time frame: From baseline (week 0) to end of treatment (week 36)

Secondary Outcomes

Change in body weight

Measured in kilograms (kg)

Time frame: From baseline (week 0) to end of treatment (week 36)

Achievement of greater than equal to (≥) 5% weight reduction

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 36)

Achievement of ≥ 10% weight reduction

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 36)

Achievement of ≥ 15% weight reduction

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 36)

Achievement of ≥ 20% weight reduction

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in body mass index (BMI)

Measured in Kilogram per meter square (Kg/m\^2)

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in waist circumference

Measured in centimeter (cm)

Time frame: From baseline (week 0) to end of treatment (week 36)

Data from ClinicalTrials.gov

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Change in glycated hemoglobin (HbA1c)

Measured in percentage point (%-point)

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in fasting plasma glucose (FPG)

Measured in millimoles per liter (mmol/L)

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in systolic blood pressure (SBP)

Measured in milliters of mercury (mmHg)

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in high sensitivity C-Reactive protein (hsCRP)

Ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in total cholesterol

Ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in high-density lipoprotein (HDL) cholesterol

Ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in low-density lipoprotein (LDL) cholesterol

Ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in triglycerides

Ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score

IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in IWQOL-Lite-CT Psychosocial composite score

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in IWQOL-Lite-CT Physical Function score

Time frame: From baseline (week 0) to end of treatment (week 36)

Change in IWQOL-Lite-CT Total score

Time frame: From baseline (week 0) to end of treatment (week 36)

Number of adverse events

Count of events

Time frame: From baseline (week 0) to end of treatment (week 40)