A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
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ClinicalTrials.gov Identifier: NCT05369390 |
Recruitment Status :
Completed
First Posted : May 11, 2022
Last Update Posted : April 11, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | May 4, 2022 | ||||||
First Posted Date ICMJE | May 11, 2022 | ||||||
Last Update Posted Date | April 11, 2024 | ||||||
Actual Study Start Date ICMJE | May 11, 2022 | ||||||
Actual Primary Completion Date | January 9, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of treatment emergent adverse events (TEAE) [ Time Frame: Part A: From pre-dose on Day 1 to 22 days; Part B: From pre-dose on Day 1 to 31 days; Part C and D: From pre-dose on Day 1 to 105 days ] Number of events
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity | ||||||
Official Title ICMJE | Safety, Tolerability and Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity | ||||||
Brief 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 active treatment and 4 participants randomised to receive placebo once-daily for 12 weeks. The dosing will be sequential, i.e., 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 cohort will be initiated. The remaining participants will be dosed in smaller groups of 8 participants separated by a safety observation period of at least 36 hours. A safety evaluation will be made between dosing of participants within a group and before moving on to a higher dose. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures. Primary Purpose: Treatment
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Condition ICMJE | Obesity | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
144 | ||||||
Original Estimated Enrollment ICMJE |
116 | ||||||
Actual Study Completion Date ICMJE | January 9, 2024 | ||||||
Actual Primary Completion Date | January 9, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Part A and B:
Part C and D:
Exclusion Criteria: Part A and B:
Part C and D:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05369390 | ||||||
Other Study ID Numbers ICMJE | NN9487-4830 U1111-1270-0852 ( Other Identifier: World Health Organization (WHO) ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Novo Nordisk A/S | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Novo Nordisk A/S | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Novo Nordisk A/S | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |