Recruiting NCT07578584
A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NNC0497-0040, Placebo.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Overweight, Obesity, Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Weekly Doses of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and in Participants With Type 1 Diabetes With Overweight or Obesity
Overview
The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.
Interventions
- Drug NNC0497-0040
NNC0497-0040 will be administered subcutaneously. - Drug Placebo
Placebo will be administered subcutaneously.
Primary outcome measures
- Number of adverse events [Time frame: Day 1 up to Week 6]
- Number of adverse events [Time frame: MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25]
- Number of adverse events [Time frame: Day 1 up to Week 25]
Secondary outcome measures (7)
- Area under the serum NNC0497-0040 concentration time curve [Time frame: Day 1]
- Cmax: Maximum observed serum NNC0497-0040 concentration [Time frame: Day 1]
- Area under the serum NNC0497-0040 concentration time curve at steady state [Time frame: MAD1-2: Week 12; MAD3: Week 20]
- Cmax: Maximum observed serum NNC0497-0040 concentration at steady state [Time frame: MAD1-2: Week 12; MAD3: Week 20]
- Number of severe hypoglycaemic episodes [Time frame: Day 1 up to Week 25]
- AUC: Area under the serum NNC0497-0040 concentration time curve during at steady state [Time frame: MAD4: Week 20]
- Cmax: Maximum observed serum NNC0497-0040 concentration at steady state [Time frame: MAD4: Week 20]
Eligibility criteria
For SAD cohorts
Inclusion criteria
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
- Body mass index between 18.5 kilogram per m\^2 and 29.9 kilogram per m\^2 (both inclusive) at screening.
- 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.
Exclusion criteria
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.
- Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
For MAD1-3 cohorts
Inclusion criteria
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
- Body mass index between 27.0 kilogram per m\^2 and 39.9 kilogram per m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered 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.
Exclusion criteria
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- HbA1c above or equal to 6.5 percentage (48 millimoles per mole) at screening.
- Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
For MAD4 cohorts
Inclusion criteria
- Male aged 18-55 years (both inclusive) at screening.
- Body mass index between 27.0 kilogram per m\^2 and 34.9 kilogram per m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Diagnosed with type 1 diabetes mellitus above or equal to 1 year before screening.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) more than 90 days prior to the day of screening.
- Use of continuous glucose monitoring (CGM) device more than 90 consecutive days prior to the day of screening.
- HbA1c in the range of 7.2percentage - 9.5percentage (both inclusive).
Exclusion criteria
- Any disorder, unwillingness or inability, except for mild conditions under stable treatment associated with type 1 diabetes (T1D), which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).
- Use of any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening or in the period between screening and randomisation.
- Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers or growth hormone.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
- Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Profil Institut für Stoffwechselforschung GmbH — Neuss
Identifiers
NCT: NCT07578584 · NN6497-8309 · U1111-1325-4319 · 2025-523978-16