A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.
- Conditions
- Overweight, Obesity
- Interventions
- Drug: NNC0487-0111 ADrug: Placebo A
- Registration Number
- NCT07121153
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 36
- 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.
- Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
- 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.
- 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.
-
Any condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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HbA1c ≥ 6.5 percent (%) [48 milimol per mole (mmol/mol)] at screening.
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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 (<) 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort A1 NNC0487-0111 A 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. Cohort A1 Placebo A 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. Cohort A2 NNC0487-0111 A 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. Cohort A2 Placebo A 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. Cohort A3 NNC0487-0111 A 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. Cohort A3 Placebo A 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.
- Primary Outcome Measures
Name Time Method Number of treatment emergent adverse events (TEAEs) From NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23) Number of events
- Secondary Outcome Measures
Name Time Method AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose From pre-dose on Day 1 until completion of the end of study visit (Day 23) h\*nmol/L
Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose From pre-dose on Day 1 until completion of the end of study visit (Day 23) nmol/L
tmax,SD; the time of maximum plasma concentration of NNC0487-0111 after a single dose From pre-dose on Day 1 until completion of the end of study visit (Day 23) h
t1/2,SD; the terminal half-life of NNC0487-0111 after a single dose From pre-dose on Day 1 until completion of the end of study visit (Day 23) h
Relative change in body weight From baseline Day 1 until completion of the end of study visit (Day 23) Change in fasting plasma glucose From baseline Day 1 until completion of the end of study visit (Day 23) mmol/L
Trial Locations
- Locations (1)
Jinan Central Hospital
🇨🇳Ji'Nan, Shandong, China
Jinan Central Hospital🇨🇳Ji'Nan, Shandong, China