A Phase 1 interventional study of NNC0497-0040 and Placebo in Type 1 Diabetes (T1D), Overweight and Obesity, sponsored by Novo Nordisk A/S. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 146 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
For SAD cohorts
Inclusion Criteria:
Exclusion Criteria:
For MAD1-3 cohorts
Inclusion Criteria:
Exclusion Criteria:
For MAD4 cohorts
Inclusion Criteria:
Exclusion Criteria:
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Drug: NNC0497-0040 · Drug: Placebo
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Drug: NNC0497-0040 · Drug: Placebo
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Drug: NNC0497-0040 · Drug: Placebo
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Drug: NNC0497-0040 · Drug: Placebo
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Drug: NNC0497-0040 · Drug: Placebo
NNC0497-0040 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Number of adverse events
Measured in events
Time frame: Day 1 up to Week 6
Number of adverse events
Measured in events
Time frame: MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25
Number of adverse events
Measured in events
Time frame: Day 1 up to Week 25
Area under the serum NNC0497-0040 concentration time curve
Measured in hours \* nanomoles per litre (h\*nmol/L)
Time frame: Day 1
Cmax: Maximum observed serum NNC0497-0040 concentration
Measured in nanomoles per litre (nmol/L)
Time frame: Day 1
Area under the serum NNC0497-0040 concentration time curve at steady state
Measured in hours \* nanomoles per litre (h\*nmol/L)
Time frame: MAD1-2: Week 12; MAD3: Week 20
Cmax: Maximum observed serum NNC0497-0040 concentration at steady state
Measured in nanomoles per litre (nmol/L)
Time frame: MAD1-2: Week 12; MAD3: Week 20
Number of severe hypoglycaemic episodes
Measured in events
Time frame: Day 1 up to Week 25
AUC: Area under the serum NNC0497-0040 concentration time curve during at steady state
Measured in hours \* nanomoles per litre (h\*nmol/L)
Time frame: MAD4: Week 20
Cmax: Maximum observed serum NNC0497-0040 concentration at steady state
Measured in nanomoles per litre (nmol/L)
Time frame: MAD4: Week 20
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S