A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity

Novo Nordisk A/S57 enrolled

Overview

This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Metabolism and Nutrition Disorder Obesity

Interventions

Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent * Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported) * Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s) * Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator * Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit Exclusion Criteria: * Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening * History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator

Outcomes

Primary Outcomes

Number of treatment emergent adverse events (TEAEs)

count of events

Time frame: From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)

Secondary Outcomes

Change in heart rate

measured in beats per minute

Time frame: Baseline (Day 1), Follow-up (Day 112)

Change in biochemistry

Parameters: Calcium (total), Chloride, Magnesium, Phosphate (inorganic), Potassium, Sodium, Urea (blood urea nitrogen, BUN), Uric acid, Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Amylase, Aspartate aminotransferase (AST), Creatinine kinase (CK, total), Gamma glutamyltransferase (GGT), Lactase dehydrogenase, Lipase, Albumin, Bicarbonate, Bilirubin (total), Creatinine, High sensitivity C-reactive protein (hsCRP) and Total protein in SI units