NCT03479892

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

A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Not accepted

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

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	NNC0194-0499	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.
DRUG	Placebo	Participants will receive once weekly injections of NNC0194-0499 matched placebo.

Timeline

• Start date: 2018-03-13
• Primary completion: 2019-06-04
• Completion: 2019-06-04
• First posted: 2018-03-27
• Last updated: 2019-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study