Who may be eligible for this overweight, obesity, and type 1 diabetes clinical trial?

Adults between 18 and 55 years old who are male or females not able to have children may be eligible. Participants can be healthy with normal or overweight, or have type 1 diabetes with overweight. Some health conditions and medication use may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this overweight, obesity, and type 1 diabetes clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from the study sites may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 55Years

All Genders

ID07578584

Study of Weekly Subcutaneous Doses of NNC0497-0040 in Healthy Adults, Adults With Overweight or Obesity, and Adults With Type 1 Diabetes and Overweight or Obesity

Q: What is NNC0497-0040 studying for overweight, obesity, and type 1 diabetes?

NNC0497-0040 is being studied to see if it is safe, tolerable, and how it works in healthy adults with normal or excess weight, adults with overweight or obesity, and adults with type 1 diabetes who are overweight. This clinical trial by Novo Nordisk A/S aims to learn more about the effects of this new treatment compared to a placebo.

Led by Novo Nordisk A/S · Updated on 2026-06-04

146

Participants Needed

Research Sites

N/A

Total Duration

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 AS. 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

Age: 18Years - 55Years

All Genders

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)

Research Team

Novo Nordisk

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Study of Weekly Subcutaneous Doses of NNC0497-0040 in Healthy Adults, Adults With Overweight or Obesity, and Adults With Type 1 Diabetes and Overweight or Obesity

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria