Completed

NNC0174-0833 for Weight Management: A Dose Finding Study

Study Aim

This phase 2 study aims to find the appropriate dose of NNC0174-0833 for weight management by observing the percentage change in body weight from the start to the 26th week in participants who adhere to the treatment.

What is being tested

NNC0174-0833

+ Placebo (NNC0174-0833)

+ Liraglutide 3.0 mg

Drug

Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

Over 18 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: March 2019

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2019

Actual date on which the first participant was enrolled.

This study focuses on exploring the safety and effectiveness of a medication called NNC0174-0833 for weight management. The trial involves individuals who will take either NNC0174-0833, another medication named liraglutide, or a placebo (a 'dummy' medicine). The importance of this study lies in finding a potential new treatment to help people manage their weight. Alongside the medication, participants will receive guidance on making healthier food choices and increasing physical activity to support weight loss. Throughout the study, participants will need to take one injection either once a week or once a day, depending on the assigned treatment. These injections are administered using a thin needle in a skin fold, in areas like the stomach, thigh, or upper arm. The study lasts about 8 months, during which participants will have 12 clinic visits with the study doctor. The primary outcome being evaluated is the change in body weight from the beginning to the end of the study. This is measured both during the active trial period and when participants are adhering to their treatment plan.

Official TitleInvestigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.

NCT03856047

Principal SponsorNovo Nordisk A/S

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

706 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

3 inclusion criteria required to participate

18 years or older at the time of signing the informed consent.

Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').

BMI equal to 30.0 kg/m^2 or greater or BMI equal to 27.0 kg/m^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).

2 exclusion criteria prevent from participating

HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.

A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

12 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group II

Experimental

Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group III

Experimental

Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group IV

Experimental

Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group 5

Experimental

Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group 6

Placebo

Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group 7

Placebo

Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group 8

Placebo

Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group 9

Placebo

Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group 10

Placebo

Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group 11

Active Comparator

Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.

Group 12

Placebo

Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 54 locations

Suspended

Anaheim Clinical Trials, LLC

Anaheim, United StatesOpen Anaheim Clinical Trials, LLC in Google Maps

Suspended

Encompass Clinical Research

Spring Valley, United States

Suspended

Nature Coast Clinical Research

Crystal River, United States

Suspended

Jacksonville Center For Clinical Research

Jacksonville, United States

Completed54 Study Centers