A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: NNC0487-0111 A; Drug: Placebo A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07121153

U1111-1311-5582 (Other Identifier)

NN9490-8213

Details and patient eligibility

About

The study is testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human body. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) and which treatment they get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors but has previously been tested in humans. This study will last for up to 53 days.

Enrollment: 36 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
3. Body mass index between 24.0 and 34.9 kg/m2 (both inclusive) at screening. Overweight and obesity should be due to excess adipose tissue, as judged by the investigator, with a body weight (more than or equal to) ≥ 65.0 kg at screening.
4. 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

1. Any condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

2. HbA1c ≥ 6.5 percent (%) [48 milimol per mole (mmol/mol)] at screening.

3. Any laboratory safety parameters at screening outside the below laboratory ranges:

   • Vitamin D (25-hydroxycholecalciferol) less than (<) 12 nanogram per mililiter (ng/mL) [30 nanometer (nM)] at screening
   • Parathyroid hormone (PTH) outside normal range at screening
   • Total calcium outside normal range at screening
   • Amylase ≥ 2 times upper limit of normal at screening
   • Lipase ≥ 2 times upper limit of normal at screening
   • Calcitonin ≥ 50 picogram per mililiter (pg/mL) at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Cohort A1

Experimental group

Description:

Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo.

Treatment:

Drug: Placebo A

Drug: NNC0487-0111 A

Cohort A2

Experimental group

Description:

Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo.

Treatment:

Drug: Placebo A

Drug: NNC0487-0111 A

Cohort A3

Experimental group

Description:

Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo.

Treatment:

Drug: Placebo A

Drug: NNC0487-0111 A