- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04259801
First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes
Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of NNC0480-0389 in Combination With Semaglutide s.c.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Groningen, Netherlands, 9728 NZ
- Novo Nordisk Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Part 1:
- Male aged 18-45 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Part 2 (not applicable for proof-of-concept (PoC) cohort):
- Body mass index between 20.0 kg/m^2 and 39.9 kg/m^2 (both inclusive).
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
- Considered to be eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Part 2 (only applicable for PoC cohort):
- Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive). Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.
- Female of non-childbearing potential or male aged 18-64 years (both inclusive) at the time of signing informed consent.
- Considered to be eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Diagnosed with type 2 diabetes at least 90 days prior to the day of screening.
- Subjects treated with diet and exercise as monotherapy or in combination with 1-2 of the following anti-diabetic drug(s) at a stable dose for at least 30 days prior to screening: metformin, sulfonylureas, meglitinides, DPP-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, GLP-1 receptor agonists or SLGT-2 inhibitors. The metformin dose should be between 1500 mg to 3000 mg or maximum tolerated or effective dose documented in subject's medical record.
- Glycosylated haemoglobin (HbA1c) in the range of 6.5% (inclusive) and 10% (non-inclusive).
Exclusion Criteria:
Part 1:
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- HbA1c equal to or above 6.5 % (48 mmol/mol) at screening.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening. Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Part 2 (not applicable for PoC cohort):
- Any disorder (except for conditions associated with T2D for the PoC cohort) which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D for PoC Cohort).
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
- HbA1c equal to or above 6.5 % (48 mmol/mol) at screening.
Part 2 (only applicable for PoC cohort):
- Any disorder (except for conditions associated with T2D for the PoC cohort) which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with T2D for PoC Cohort).
- Use of any prohibited medications as listed in the protocol within 14 days of screening.
- Use of prescribed medications at the time of screening at a dose that had not been stable within 30 days prior to screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NNC0480-0389 and semaglutide
Part 1: 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide. Part 2: 12 subjects will receive 4 doses of s.c. NNC0480-0389 co-administered with s.c. semaglutide, after 8 weeks of dosing with s.c semaglutide. |
Part 1: A single dose of NNC0480-0389, dose increased in each cohort.
Part 2: Weekly doses (for 4 weeks) of NNC0480-0389, dose increased in each cohort.
Part 1: Single dose of semaglutide (0.5 mg).
Part 2: Weekly doses of semaglutide alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
|
Experimental: NNC0480-0389 and placebo (semaglutide)
Part 1: 4 subjects will receive a single dose of s.c. NNC0480-0389 co-administered with semaglutide placebo. Part 2: 4 subjects will receive 4 doses of s.c. NNC0480-0389, co-administered with semaglutide placebo after 8 weeks of dosing with semaglutide placebo. |
Part 1: A single dose of NNC0480-0389, dose increased in each cohort.
Part 2: Weekly doses (for 4 weeks) of NNC0480-0389, dose increased in each cohort.
Placebo for NNC0480-0389.
Part 1: A single dose of placebo (NNC0480-0389), dose increased in each cohort.
Part 2: Weekly doses (for 4 weeks) of placebo A, dose increased in each cohort.
|
Active Comparator: Placebo (NNC0480-0389) with semaglutide
Part 1: 2 subjects will receive a single dose of placebo (NNC0480-0389), co-administered with s.c. semaglutide. Part 2: 4 subjects will receive 4 doses of placebo (NNC0480-0389), co-administered with s.c. semaglutide, after 8 weeks of dosing with s.c. semaglutide |
Part 1: Single dose of semaglutide (0.5 mg).
Part 2: Weekly doses of semaglutide alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
Part 1: Single dose of placebo (semaglutide) (0.5 mg).
Part 2: Weekly doses of placebo (semaglutide) alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
|
Placebo Comparator: Placebo (NNC0480-0389) with placebo (semaglutide)
Part 1: 3 subjects will receive a single dose of placebo (NNC0480-0389), co-administered with semaglutide placebo. Part 2: 2 subjects will receive 4 doses of placebo (NNC0480-0389), co-administered with semaglutide placebo, after 8 weeks of dosing with semaglutide placebo. |
Placebo for NNC0480-0389.
Part 1: A single dose of placebo (NNC0480-0389), dose increased in each cohort.
Part 2: Weekly doses (for 4 weeks) of placebo A, dose increased in each cohort.
Part 1: Single dose of placebo (semaglutide) (0.5 mg).
Part 2: Weekly doses of placebo (semaglutide) alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of treatment emergent adverse events (TEAE) in Part 1
Time Frame: From time of dosing (day 1) until completion of follow-up visit (day 71)
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Number of events
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From time of dosing (day 1) until completion of follow-up visit (day 71)
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Number of treatment emergent adverse events (TEAE) in Part 2
Time Frame: From first combination dosing (day 57) until completion of follow-up visit (day 148)
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Number of events
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From first combination dosing (day 57) until completion of follow-up visit (day 148)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the NNC0480-0389 plasma concentration-time curve from time
Time Frame: From baseline (day 1) to post treatment follow-up (day 71)
|
h∙nmol/L
|
From baseline (day 1) to post treatment follow-up (day 71)
|
Maximum plasma concentration of NNC0480-0389 after administration of a single dose
Time Frame: From baseline (day 1) to post treatment follow-up (day 71)
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nmol/L
|
From baseline (day 1) to post treatment follow-up (day 71)
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Area under the semaglutide plasma concentration time curve from time of dosing to infinity after administration of a single dose
Time Frame: From baseline (day 1) to post treatment follow-up (day 71)
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h∙nmol/L
|
From baseline (day 1) to post treatment follow-up (day 71)
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The maximum concentration of semaglutide after administration of a single dose
Time Frame: From baseline (day 1) to post treatment follow-up (day 71)
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nmol/L
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From baseline (day 1) to post treatment follow-up (day 71)
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Area under the NNC0480-0389 plasma concentration-time curve from 0 to 168 hours after administration of the 4th dose of NNC0480-0389 in week 12
Time Frame: From administration of dose in week 12 (day 78) to day 85
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h∙nmol/L
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From administration of dose in week 12 (day 78) to day 85
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Maximum plasma concentration of NNC0480-0389 after administration of the 4th dose of NNC0480-0389 in week 12
Time Frame: From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)
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nmol/L
|
From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)
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Area under the semaglutide plasma concentration-time curve from 0-168 hours after administration of the 12th dose of semaglutide
Time Frame: From administration of dose in week 12 (day 78) to day 85
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h∙nmol/L
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From administration of dose in week 12 (day 78) to day 85
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The maximum concentration of semaglutide after administration of the 12th dose of semaglutide
Time Frame: From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)
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nmol/L
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From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Reporting Anchor & Disclosure (1452), Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9389-4536
- 2019-002857-44 (Registry Identifier: European Medicines Agency (EudraCT))
- U1111-1236-4114 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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