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Completed

NCT Number: NCT05369390

A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity

NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in humans. This study also look at how the study medicine affects body weight and how to improve the treatment of people with overweight, obesity or related diseases.

This study will have 4 parts: Part A, B, C and D. Part A: This is planned to consist of five groups, one additional group may be added. Each group will include 8 participants, with 6 participants being randomised to receive a single dose of NNC0487-0111 A and 2 participants randomised to receive placebo. The dosing within each group will be sequential, i.e., 2 sentinel participants (1 on active and 1 on placebo).

Part B: This is planned to consist of three groups, one additional group may be added. Each group will include 12 participants, with 9 participants being randomised to receive NNC0487-0111 A and 3 participants randomised to receive placebo once daily for 10 days. The dosing within each group will be sequential. For the first group, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of 7 days (168 hours), before dosing of the remaining participants in the group will be initiated. For the remaining groups, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the group will be initiated.

Part C and D are matching regarding planned visits and procedures, but the study interventions in Part D (NNC0487-0111 B) differ from Part A, B and C (NNC0487-0111 A). Each part is planned to consist of one group, although one additional group may be added. Each group will include 20 participants, with 16 participants being randomised to receive active treatment and 4 participants randomised to receive placebo once-daily for 12 weeks. The dosing will be sequential, i.e., 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the cohort will be initiated. The remaining participants will be dosed in smaller groups of 8 participants separated by a safety observation period of at least 36 hours.

A safety evaluation will be made between dosing of participants within a group and before moving on to a higher dose.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC, San Antonio, Texas, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Part A and B:

  • Male or female aged 18-55 years (both inclusive) at time of signing informed consent
  • Body mass index (BMI) of 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Part C and D:

  • Male or female aged 18-55 years (both inclusive) at time of signing informed consent
  • Body mass index (BMI) of 27.0 to 39.9 kg/m^2 (both inclusive) at screening
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

Part A and B:

  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening
  • Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values
  • Vitamin D (25-hydroxycholecalciferol) less than 20 Nanograms per milliliter (ng/mL) (50 nano molar (NM)) at screening
  • Parathyroid hormone (PTH) outside normal range at screening
  • Total calcium outside normal range at screening
  • Amylase greater than or equal to 2 times upper limit of normal at screening
  • Lipase greater than or equal to 2 times upper limit of normal at screening

Part C and D:

  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening
  • Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
  • Vitamin D (25-hydroxycholecalciferol) less than 20 ng/mL (50 nM) at screening
  • Parathyroid hormone (PTH) outside normal range at screening
  • Total calcium outside normal range at screening
  • Amylase greater than or equal to 2 times upper limit of normal at screening
  • Lipase greater than or equal to 2 times upper limit of normal at screening

Treatment and study plan

NNC0487-0111 A

Drug

Participants will receive NNC0487-0111 A tablet once daily.

NNC0487-0111 B

Drug

Participants will receive NNC0487-0111 B tablet once daily.

Placebo B (NNC0487-0111 B)

Other

Participants will receive placebo matched to NNC0487-0111 B tablet once daily.

Placebo A (NNC0487-0111 A)

Other

Participants will receive placebo matched to NNC0487-0111 A tablet once daily.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAE)

    Time frame: Part A: From pre-dose on Day 1 to 22 days; Part B: From pre-dose on Day 1 to 31 days; Part C and D: From pre-dose on Day 1 to 105 days

    Number of events

Secondary outcomes

  1. Part A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 22)

    Hours*Nanomoles per liter (h*nmol/L)

  2. Part A: Cmax,SD; the maximum plasma concentration of NNC0487- 0111 after a single dose

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 22)

    Nanomoles per liter (nmol/L)

  3. Part B: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

    Time frame: From pre-dose on Day 10 until Day 11 (24 hours post-dose)

    h*nmol/L

  4. Part B: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose

    Time frame: From pre-dose on Day 10 until Day 22

    nmol/L

  5. Part C and D: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

    Time frame: From pre-dose on Day 84 until Day 85 (24 hours post-dose)

    h*nmol/L

  6. Part C and D: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose

    Time frame: From pre-dose on Day 84 until completion of the end of study visit (Day 105)

    nmol/L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety, Tolerability and Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 11, 2022
Registry last updated
Jun 15, 2025

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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