CompletedNCT03479892Updated Jun 26, 2019

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

A Phase 1 interventional study of NNC0194-0499 and Placebo in Metabolism and Nutrition Disorder and Obesity, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged 22 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 57
Allocation: Randomized
Ages: 22 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Metabolism and Nutrition Disorder
Obesity

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Who can participate

Ages eligible: 22 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 57 participants (actual)

Study arms

Experimental
NNC0194-0499
Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
Drug: NNC0194-0499
Placebo comparator
Placebo
Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
Drug: Placebo

Interventions

DrugNNC0194-0499
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.
DrugPlacebo
Participants will receive once weekly injections of NNC0194-0499 matched placebo.

What researchers measure

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
Time frame: Baseline (Day -1), Follow-up (Day 112)
Change in haematology
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)
Change in fibrinogen
measured in g/L
Time frame: Baseline (Day -1), Follow-up (Day 112)
Change in prothrombin time read as international normalised ratio (INR)
Time frame: Baseline (Day -1), Follow-up (Day 112)
Change in activated partial thromboplastin time (APTT)
measured in seconds
Time frame: Baseline (Day -1), Follow-up (Day 112)
Changes in electrocardiogram (ECG)
Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units
Time frame: Baseline (Day 1), Follow-up (Day 112)
Number of injection site reactions
count of injection site reactions
Time frame: From baseline (Day 1) to follow-up (Day 112)
Occurrence of anti-NNC0194-0499 antibodies
Time frame: From baseline (Day 1) to follow-up (Day 112)
t½,SS: the terminal serum half-life of NNC0194-0499 at steady state
Calculated based on serum concentrations of NNC0194-0499
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state
Calculated based on serum concentrations of NNC0194-0499
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state
Calculated based on serum concentrations of NNC0194-0499
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state
Calculated based on serum concentrations of NNC0194-0499
Time frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Change in systolic blood pressure
measured in mmHg
Time frame: Baseline (Day 1), Follow-up (Day 112)
Change in diastolic blood pressure
measured in mmHg
Time frame: Baseline (Day 1), Follow-up (Day 112)

Study locations

1 site

Novo Nordisk Investigational Site
San Antonio, Texas 78209, United States

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03479892
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Mar 27, 2018
Start date: Mar 13, 2018
Primary completion: Jun 4, 2019
Completion: Jun 4, 2019
Last update: Jun 26, 2019

Study contacts

Clinical Reporting Anchor and Disclosure (1452)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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