Clinical trial NCT03479892: A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity
Official title: A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 57
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)
Secondary outcomes:
measure: Change in heart rate
timeFrame: Baseline (Day 1), Follow-up (Day 112)
measure: Change in biochemistry
timeFrame: Baseline (Day -1), Follow-up (Day 112)
measure: Change in haematology
timeFrame: Baseline (Day -1), Follow-up (Day 112)
measure: Change in fibrinogen
timeFrame: Baseline (Day -1), Follow-up (Day 112)
measure: Change in prothrombin time read as international normalised ratio (INR)
timeFrame: Baseline (Day -1), Follow-up (Day 112)
measure: Change in activated partial thromboplastin time (APTT)
timeFrame: Baseline (Day -1), Follow-up (Day 112)
measure: Changes in electrocardiogram (ECG)
timeFrame: Baseline (Day 1), Follow-up (Day 112)
measure: Number of injection site reactions
timeFrame: From baseline (Day 1) to follow-up (Day 112)
measure: Occurrence of anti-NNC0194-0499 antibodies
timeFrame: From baseline (Day 1) to follow-up (Day 112)
measure: t½,SS: the terminal serum half-life of NNC0194-0499 at steady state
timeFrame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
measure: Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state
timeFrame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
measure: tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state
timeFrame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
measure: CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state
timeFrame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
measure: Change in systolic blood pressure
timeFrame: Baseline (Day 1), Follow-up (Day 112)
measure: Change in diastolic blood pressure
timeFrame: Baseline (Day 1), Follow-up (Day 112)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: