A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: NNC0487-0111; Drug: Placebo (NNC0487-0111)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06064006

NN9490-7613

U1111-1289-3282 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin

Enrollment: 125 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• 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

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

• HbA1c equal to or greater than 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) below 12 ng/mL (30 nM) at screening
  • Parathyroid hormone (PTH) outside normal range at screening
  • Total calcium outside normal range at screening
  • Amylase equal to or greater than 2 times upper limit of normal at screening
  • Lipase equal to or greater than 2 times upper limit of normal at screening
  • Calcitonin equal to or greater than 50 ng/L at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

NNC0487-0111

Experimental group

Description:

Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)

Treatment:

Drug: Placebo (NNC0487-0111)

Drug: NNC0487-0111

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).

Treatment:

Drug: Placebo (NNC0487-0111)

Drug: NNC0487-0111