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Peptide
Survodutide for Obesity and Fatty Liver Disease
Phase 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial is for adults who are overweight or obese and have a liver disease called nonalcoholic steatohepatitis (NASH). The purpose of the study is to see if a medication called
Who is the study for?
Adults over 18 with obesity or overweight and presumed or confirmed NASH can join. They must have a BMI of at least 30, or a BMI of 27 plus a weight-related health issue like hypertension, type 2 diabetes, dyslipidemia, sleep apnea, or cardiovascular disease. Those with other chronic liver diseases are excluded.
What is being tested?
The trial tests if Survodutide reduces liver fat and aids weight loss in people with NASH and obesity/overweight. Participants are randomly assigned to receive either Survodutide doses or placebo weekly for about a year while also getting diet and exercise counseling.
What are the potential side effects?
Potential side effects aren't specified here but typically include reactions at the injection site, gastrointestinal symptoms, fatigue, allergic reactions among others based on similar treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 2 trial • 295 Patients • NCT0477127367%
Nausea
54%
Diarrhoea
48%
Vomiting
22%
COVID-19
17%
Headache
17%
Constipation
17%
Nasopharyngitis
14%
Abdominal distension
14%
Fatigue
13%
Eructation
13%
Decreased appetite
10%
Gastrooesophageal reflux disease
9%
Dyspepsia
9%
Flatulence
7%
Abdominal pain
7%
Dizziness
6%
Arthralgia
6%
Lipase increased
6%
Upper respiratory tract infection
4%
Injection site reaction
4%
Hypoglycaemia
4%
Rash
4%
Pain in extremity
4%
Back pain
4%
Myalgia
4%
Pyrexia
3%
Early satiety
3%
Procedural pain
3%
Insomnia
3%
Anaemia
3%
Influenza
3%
Abdominal pain upper
1%
Spinal compression fracture
1%
Acute myocardial infarction
1%
Squamous cell carcinoma
1%
Post procedural haemorrhage
1%
Urinary tract infection
1%
Hyperglycaemia
1%
Alopecia
1%
Nephrolithiasis
1%
Blindness transient
1%
Asthenia
1%
Sudden hearing loss
1%
Injection site bruising
1%
Malaise
1%
Cholecystitis
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Survodutide 4.8 mg - Actual Maintenance Treatment
Placebo - Actual Maintenance Treatment
Survodutide 2.4 mg - Actual Maintenance Treatment
Survodutide 6.0 mg - Actual Maintenance Treatment
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment armExperimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Survodutide
2021
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,897,135 Total Patients Enrolled
22 Trials studying Obesity
10,167 Patients Enrolled for Obesity