Actively Recruiting
Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Weekly Subcutaneous Doses of NNC0497-0040 in Healthy Adults, Adults With Overweight or Obesity, and Adults With Type 1 Diabetes With Overweight or Obesity
Led by Novo Nordisk A/S · Updated on 2026-06-04
146
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of NNC0497-0040 in healthy adults with normal weight or overweight, adults with overweight or obesity, and adults with type 1 diabetes who also have overweight or obesity. This phase 1 clinical trial aims to understand how this new treatment compares to a placebo in these different groups. The sponsor of the study is Novo Nordisk A/S. Participants will receive weekly subcutaneous injections of either NNC0497-0040 or a matching placebo. The study includes multiple groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Each participant will receive either the investigational drug or placebo for up to 29 weeks, depending on their assigned group. During the trial, participants will have regular assessments including medical exams, vital signs, electrocardiograms, and laboratory tests to monitor safety and drug effects. Researchers will track the number of adverse events from the start of treatment through various weeks depending on the cohort, along with measuring drug levels in the blood. Participants’ glucose control and hypoglycemic episodes will also be monitored, especially for those with type 1 diabetes. The total participation time may last up to 29 weeks.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female of non-childbearing potential or male aged 18-55 years at screening
- Body mass index (BMI) between 18.5 and 29.9 for SAD cohorts
- Body mass index (BMI) between 27.0 and 39.9 for MAD1-3 cohorts
- Body mass index (BMI) between 27.0 and 34.9 for MAD4 cohort
- Diagnosed with type 1 diabetes for at least 1 year for MAD4 cohort
- Treated with multiple daily insulin injections for more than 90 days prior to screening for MAD4 cohort
- Use of continuous glucose monitoring device for more than 90 consecutive days prior to screening for MAD4 cohort
- Considered healthy or eligible based on medical history, physical exam, vital signs, ECG, and lab tests as judged by investigator
- HbA1c in range 7.2% to 9.5% for MAD4 cohort
You will not qualify if you...
- Any disorder or condition that may jeopardize safety or compliance with the protocol
- Glycated hemoglobin (HbA1c) equal to or above 6.5% for SAD and MAD1-3 cohorts
- Presence or history of clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions except those associated with diabetes and obesity for MAD4 cohort
- Use of medications for diabetes or obesity other than stated within 90 days before screening or between screening and randomization for MAD4 cohort
- Current treatment with systemically effective corticosteroids, MAO inhibitors, systemic non-selective beta-blockers, or growth hormone
- Anticipated change or start of medications affecting weight or glucose metabolism
- Unwilling or unable to refrain from use of prescription or non-prescription medicines, herbal products, or non-routine vitamins within 14 days prior to dosing (except occasional paracetamol or ibuprofen until 24 hours prior)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 25 weeks depending on cohort assignment
Participants receive weekly subcutaneous doses of NNC0497-0040 or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Weekly visits for dosing and assessments
Trial Site Locations
Total: 1 location
1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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