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Group 3 for Non-alcoholic Fatty Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-55 years (both inclusive) at the time of signing informed consent
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (post-dose) to day 197 (groups 1 and 2) and day 1 (post-dose) to day 57 (group 3)
Awards & highlights

Study Summary

This trial is testing a combination of 2 drugs to treat NASH, a serious liver disease. One is a new drug that works in the liver and the other is already used to treat diabetes. Participants get 1 or both drugs for either 13 or 33 weeks.

Who is the study for?
This trial is for adults aged 18-55 with a BMI of 25 to 35 who are generally healthy. Women must not be pregnant, breastfeeding, or planning pregnancy without effective contraception. Participants should not have joined another study recently or be taking certain medications.Check my eligibility
What is being tested?
The study compares the blood levels of two medicines (NNC0194-0499 and semaglutide) when given together as one formulation versus separately for treating NASH—a liver disease. Treatments are assigned randomly and the study duration varies between 13 to 33 weeks by chance.See study design
What are the potential side effects?
Potential side effects aren't specified here, but typically drugs like semaglutide can cause digestive issues, changes in appetite, risk of low blood sugar, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (post-dose) to day 197 (groups 1 and 2) and day 1 (post-dose) to day 57 (group 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (post-dose) to day 197 (groups 1 and 2) and day 1 (post-dose) to day 57 (group 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC 0-168 hour (h), 0499, steady state (SS): Area under the NNC0194-0499 concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide
AUC 0-168h,sema,SS: Area under the semaglutide concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide
Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide
Secondary outcome measures
AUC 0-168h, 0499, SS: Area under the NNC0194-0499 concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide
AUC 0-168h, sema , SS: Area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of semaglutide in combination with NNC0194-0499
Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
Participants will receive 4 weekly injections of NNC0194-0499/Semaglutide A 40/0.33 mg/mL co-formulation at the dose level of 30mg/0.25 mg.
Group II: Group 2Experimental Treatment1 Intervention
Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (3.1mg/0.25mg for Weeks 1-4, 6.3mg/0.5mg for Weeks 5-8, 12.5mg/1.0mg for Weeks 9-12, 21.3mg/1.7mg for Weeks 13-16 and 30mg/2.4mg for weeks 17-20). Participants will receive NNC0194-0499/Semaglutide 40/3.20 mg/mL co-formulation at the target dose of 30mg/2.4mg during the weeks 21-24 (maintenance dosing period).
Group III: Group 1Experimental Treatment3 Interventions
Participants will receive separate injections of NNC0194-0499 B and Semaglutide B for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (30 mg NNC0194-0499 B and 0.24 mg Semaglutide B for Weeks 1-4, 30 mg NNC0194-0499 B and 0.5 mg Semaglutide B for Weeks 5-8, 30 mg NNC0194-0499 B and 1.0 mg Semaglutide B for Weeks 9-12, 30 mg NNC0194-0499 B and 1.7 mg Semaglutide B for Weeks 13-16 and 30 mg NNC0194-0499 B and 2.4 mg Semaglutide B for Weeks 17-20). Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation at the target dose of 30/2.4 mg during the weeks 21-24 (maintenance dosing period).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0194-0499
2017
Completed Phase 1
~280
Semaglutide
2019
Completed Phase 4
~5160
NNC0194-0499/Semaglutide A (40/3.20 mg/mL)
2023
Completed Phase 1
~60
NNC0194-0499/Semaglutide A (40/0.33mg/mL)
2023
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,976 Total Patients Enrolled
17 Trials studying Non-alcoholic Fatty Liver Disease
4,292 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical Transparency dept.2834Study DirectorNovo Nordisk A/S

Media Library

NNC0194-0499 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05766709 — Phase 1
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: NNC0194-0499 Highlights & Side Effects. Trial Name: NCT05766709 — Phase 1
NNC0194-0499 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766709 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Group 3, Group 2, Group 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is Group 1 for those receiving treatment?

"Our team at Power determined that Group 1 has limited clinical data supporting its safety and efficacy, resulting in a score of 1."

Answered by AI

Are further participants being sought for this trial?

"According to the records available on clinicaltrials.gov, enrollment for this particular trial has been halted; it was first posted in February of 2023 and was last updated in March of that same year. Fortunately, there are 239 other trials with open participation at present."

Answered by AI

Is this research endeavor open to seniors aged 55 or older?

"The patient recruitment criteria for this trial requires individuals to be aged 18 - 55. Those under the age of 18 may qualify for one of the alternative trials, which number up to a total of eighteen studies, while those over 65 have access to 198 different medical trials."

Answered by AI

Am I eligible to contribute to this clinical research endeavor?

"Those that meet the criteria of non-alcoholic fatty liver disease and are between 18 - 55 years old may be accepted into this medical trial. The aim is to recruit approximately 48 patients."

Answered by AI

What is the intended outcome of this investigation?

"Novo Nordisk A/S, the study's sponsor, has identified several main objectives to measure between Days 134 (pre-dose) and 141 (168 hours post-dose). These include: assessing Area Under Curve 0–168h sema Steady State for NNC0194-0499 in combination with semaglutide; maximum concentration of NNC0194–0499 at steady state after dosing of NNC0194-0499 combined with semaglutide; and the maximal level of Semaglutide when administered alongside NNC0194-0499. All values will be measured"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations
2023. "A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766709.
~25 spots leftby Apr 2025
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