Novo Nordisk Investigational Site
San Antonio, Texas, 78209, United States
NCT Number: NCT03479892
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.
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Notify Me22 year–55 year
All sexes
Interventional
Phase 1
San Antonio, Texas, 78209, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will receive once weekly injections of NNC0194-0499 matched placebo.
Time frame: From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)
count of events
Time frame: Baseline (Day 1), Follow-up (Day 112)
measured in beats per minute
Time frame: Baseline (Day -1), Follow-up (Day 112)
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
Time frame: Baseline (Day -1), Follow-up (Day 112)
Parameters: Erythrocytes, Reticulocytes, Thrombocytes, Leucocytes (total), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV) and Mean corpuscular haemoglobin concentration (MCHC) in SI units
Time frame: Baseline (Day -1), Follow-up (Day 112)
measured in g/L
Time frame: Baseline (Day -1), Follow-up (Day 112)
Time frame: Baseline (Day -1), Follow-up (Day 112)
measured in seconds
Time frame: Baseline (Day 1), Follow-up (Day 112)
Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units
Time frame: From baseline (Day 1) to follow-up (Day 112)
count of injection site reactions
Time frame: From baseline (Day 1) to follow-up (Day 112)
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Calculated based on serum concentrations of NNC0194-0499
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Calculated based on serum concentrations of NNC0194-0499
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Calculated based on serum concentrations of NNC0194-0499
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Calculated based on serum concentrations of NNC0194-0499
Time frame: Baseline (Day 1), Follow-up (Day 112)
measured in mmHg
Time frame: Baseline (Day 1), Follow-up (Day 112)
measured in mmHg
Novo Nordisk A/S
Industry
A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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