Completed

NNC0247-0829 Injections for Weight Management in Adults with Overweight or Obesity

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Study Aim

This study aims to evaluate the safety of NNC0247-0829 injections in adults with overweight or obesity by observing the number of treatment emergent adverse events.

What is being tested

NNC0247-0829

+ Placebo (NNC0247-0829)

Drug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 60 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: July 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: July 11, 2019

Actual date on which the first participant was enrolled.

This study focuses on a potential new medicine for weight management, NNC0247-0829, in adults with overweight or obesity. The goal is to understand how this medicine works in the body, its safety, and how well it's tolerated. The study involves participants who will receive either NNC0247-0829 or a placebo, a substance that looks like the real medicine but doesn't contain any active ingredients. It's important to note that NNC0247-0829 is still in the experimental stage and hasn't been approved by the US Food and Drug Administration (FDA) yet. Depending on the group they're assigned to, participants will receive either a single injection or a series of four injections, given one week apart. These injections are administered by a study nurse at the clinic. The study lasts about 18 months, but individual participation ranges from 11 to 23 weeks, depending on the group. Participants will attend several clinic visits, where they'll have blood tests and other health checks. They'll also be asked about their health history and habits, including mental health. The study's primary outcomes include counting the number of treatment-related side effects for both single and multiple dose groups.

Official TitleInvestigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity
NCT04010786
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

103 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.

From 18 to 60 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

2 inclusion criteria required to participate
Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.
Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m^2 (both inclusive) in the MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.
3 exclusion criteria prevent from participating
Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.
Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.

Study Plan

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

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Up to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment

Group II

Placebo
In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo

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 1 location

Suspended

ICON Early Phase Services, LLC

San Antonio, United StatesOpen ICON Early Phase Services, LLC in Google Maps
CompletedOne Study Center
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