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NCT05369390 · ClinicalTrials.gov registry record · Phase 1
A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
A Phase 1 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
NCT05369390 is a Phase 1 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 144 participants.
The verdict
NCT05369390, a Phase 1 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
Study Summary
NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in humans. This study also look at how the study medicine affects body weight and how to improve the treatment of people with overweight, obesity or related diseases. This study will have 4 parts: Part A, B, C and D. Part A: This is planned to consist of five groups, one additional group may be added. Each group will include 8 participants, with 6 participants being randomised to receive a single dose of NNC0487-0111 A and 2 participants randomised to receive placebo. The dosing within each group will be sequential, i.e., 2 sentinel participants (1 on active and 1 on placebo). Part B: This is planned to consist of three groups, one additional group may be added. Each group will include 12 participants, with 9 participants being randomised to receive NNC0487-0111 A and 3 participants randomised to receive placebo once daily for 10 days. The dosing within each group will be sequential. For the first group, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of 7 days (168 hours), before dosing of the remaining participants in the group will be initiated. For the remaining groups, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the group will be initiated. Part C and D are matching regarding planned visits and procedures, but the study interventions in Part D (NNC0487-0111 B) differ from Part A, B and C (NNC0487-0111 A). Each part is planned to consist of one group, although one additional group may be added. Each group will include 20 participants, with 16 participants being randomised to receive
Interventions
- DRUG NNC0487-0111 A
- DRUG NNC0487-0111 B
- OTHER Placebo B (NNC0487-0111 B)
- OTHER Placebo A (NNC0487-0111 A)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2022-05-11 |
| Est. Completion | 2024-01-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05369390
The ClinicalTrials.gov registry entry for NCT05369390 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which NNC0487-0111 A is the first listed.
NCT05369390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05369390 about?
NCT05369390 is a clinical study titled "A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity". NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in human...
What is the current status of trial NCT05369390?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2022-05-11. Estimated completion is 2024-01-09.
What interventions are being tested in trial NCT05369390?
The interventions under investigation include: NNC0487-0111 A (DRUG), NNC0487-0111 B (DRUG), Placebo B (NNC0487-0111 B) (OTHER), Placebo A (NNC0487-0111 A) (OTHER).
Who is sponsoring clinical trial NCT05369390?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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