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Completed

NCT Number: NCT04010786

A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity

This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NNC0247-0829

Drug

Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.

Placebo (NNC0247-0829)

Drug

Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.

Primary outcomes

  1. For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of first dosing (Day 1) until Day 71

    Number of events

  2. For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of first dosing (Day 1) until Day 85

    Number of events

Secondary outcomes

  1. For SD cohorts: Number of injection site reactions

    Time frame: From time of first dosing (Day 1) until Day 71

    Number of events

  2. For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies

    Time frame: From time of first dosing (Day 1) until Day 71

    Number of events

  3. For MD cohorts: Number of injection site reactions

    Time frame: From time of first dosing (Day 1) until Day 85

    Number of events

  4. For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies

    Time frame: From time of first dosing (Day 1) until Day 85

    Number of events

  5. For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort)

    nmol/L*h

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2019
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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