A Phase 1 interventional study of Semaglutide and Placebo in Hepatobiliary Disorders and Non-alcoholic Fatty Liver Disease, sponsored by Novo Nordisk A/S. Completed at 2 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
Among 16 studies testing semaglutide in Non-alcoholic Fatty Liver Disease — 4 open to participants now, 8 under way, 1 of them phase 3. Semaglutide · Non-alcoholic Fatty Liver Disease.
Among the 16 studies testing semaglutide in Non-alcoholic Fatty Liver Disease, this one is the 10th largest by enrollment, is the only one that started in 2017, is the only one in phase 1, and was the 2nd registered.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →4 of the 16 studies testing semaglutide in Non-alcoholic Fatty Liver Disease are open now, in 3 countries. Recruiting first, the newest first:
University of Virginia · Sites in United States
Dr Adnan Agha · Sites in United Arab Emirates
RenJi Hospital · Sites in China
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Sites in United States
By country, each count listing its studies:
Semaglutide: first FDA approval 2017 (OZEMPIC), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 221 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 126 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, semaglutide is the treatment under test here. Read study by study →
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 2 · Phase 4 3
First in 2016; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 67 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 88 across the 16 interventional studies. Of the 8 that completed or were terminated, 5 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 16 have an industry lead sponsor. The 10 most frequent:
Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
12 studies in Non-alcoholic Fatty Liver Disease by Novo Nordisk A/S: none open now, 2 under way, 1 of them phase 3. Of 10 finished, 2 (20%) have results posted.
Among the 12 studies in Non-alcoholic Fatty Liver Disease by Novo Nordisk A/S, this one is the 5th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2017, is one of 7 in phase 1, and was the 2nd registered.
Novo Nordisk A/S’s Non-alcoholic Fatty Liver Disease studies by the year they started, since 2016.
3 of the studies testing semaglutide in Non-alcoholic Fatty Liver Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05195944University Health Network, TorontoSemaglutide vs Sitagliptin | 2026-12 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT06005012University of California, San DiegoSemaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM | 2026-12-31 |
Among the 16 studies testing semaglutide in Non-alcoholic Fatty Liver Disease, from their registry updates:
Among Novo Nordisk A/S’s 12 in Non-alcoholic Fatty Liver Disease:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is looking at the effect of semaglutide on subjects with nonalcoholic fatty liver disease.This study is comparing the change in early stages of scar tissue in the liver and fat deposition in the liver in people taking semaglutide and placebo (a dummy medicine).
Participants will either get semaglutide or placebo; which treatment participants get is decided by chance. Semaglutide is a medicine under clinical investigation. That means that the medicine has not yet been approved by the authorities. Participants will need to self-inject medicine once daily for 72 weeks. The medicine should be injected under the skin in the stomach, thigh or upper arm.
There are about 3 weeks before participants start the study medicine and 7 weeks after you stop it. The study will last for about 82 weeks in total.
Participants will have 12 clinic visits, 6 phone calls and 4 visits to an MRI centre.
The study includes MRI scans of the stomach. The MRI scans will take place at a different location. Participants will be excluded from the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 67 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Compared within Non-alcoholic Fatty Liver Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Digestive System Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Semaglutide will be initiated with a starting dose of 0.05 mg/day for the first 4 weeks. The dose will be increased every 4 weeks until the target dose of 0.4 mg/day has been reached.
Drug: Semaglutide
Placebo will be initiated with a starting volume corresponding to 0.05 mg/day of semaglutide for the first 4 weeks. The volume will then be increased every 4 weeks until the target volume corresponding to 0.4 mg/day of semaglutide has been reached.
Drug: Placebo
Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.
Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.
Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Measured in KPa
Time frame: Up to day -20, week 48
Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Measured in KPa
Time frame: Up to day -20, week 24
Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Measured in KPa
Time frame: Up to day -20, week 72
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Time frame: Up to day -20, week 24
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Time frame: Up to day -20, week 48
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Time frame: Up to day -20, week 72
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Time frame: Up to day -20, week 24
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in L
Time frame: Up to day -20, week 48
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in L
Time frame: Up to day -20, week 72
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Number of subjects
Time frame: Weeks 0 - 24
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Number of subjects
Time frame: Weeks 0 - 48
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Number of subjects
Time frame: Weeks 0 - 72
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Number of subjects
Time frame: Weeks 0 - 24
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Number of subjects
Time frame: Weeks 0 - 48
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Number of subjects
Time frame: Weeks 0 - 72
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Time frame: Up to day -20, week 24
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Time frame: Up to day -20, week 48
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Time frame: Up to day -20, week 72
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Time frame: Up to day -20, week 24
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Time frame: Up to day -20, week 48
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Time frame: Up to day -20, week 72
Change in Body weight (% and kg)
Measured in kg and %
Time frame: Week 0, week 48
Change in Body weight (% and kg)
Measured in kg and %
Time frame: Week 0, week 72
Change in Waist circumference
Measured in cm
Time frame: Week 0, week 48
Change in Waist circumference
Measured in cm
Time frame: Week 0, week 72
Change in Body mass index (BMI)
Measured in kg/sqm
Time frame: Week 0, week 48
Change in Body mass index (BMI)
Measured in kg/sqm
Time frame: Week 0, week 72
Number of treatment-emergent adverse events (TEAEs)
Count of adverse events
Time frame: Weeks 0 - 48
Number of treatment-emergent adverse events (TEAEs)
Count and % of adverse events
Time frame: Weeks 0 - 79
Number of treatment-emergent hypoglycaemic episodes
Count of episodes
Time frame: Weeks 0 - 48
Number of treatment-emergent hypoglycaemic episodes
Count of episodes
Time frame: Weeks 0 - 79
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
Ran from Nov 2017 to primary completion in Mar 2020, 27 months.
Of 104 industry-sponsored phase 1 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 27 months is above that.
Counting every sponsor, half of 125 studies reached it within 10 months; a quarter within 5 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide
Non-alcoholic Fatty Liver Disease →