Survodutide trials recruiting now

Who the trial lists, as registered

Lists people 18 and older. Conditions: Metabolic Dysfunction Associated Steatohepatitis (MASH); Liver Fibrosis.

• Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent
• Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
• Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used
• Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply

The exclusion criteria are on the listing.

What it tests, as registered

Survodutide; Placebo

Registered summary

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The full summary is on the listing.

Where, as registered

165 US sites in 30 states; also China (58), Japan (57), United Kingdom (24), Germany (18), India (15), France (14), Italy (12), Argentina (11), South Korea (11), Taiwan (11), Brazil (10), Australia (9), Belgium (9), Canada (9), Poland (9), Mexico (8), Spain (8), Turkey (Türkiye) (8), Bulgaria (7), Austria (6), Netherlands (6), Romania (6), Hungary (4), Malaysia (4), New Zealand (4), Switzerland (4), Chile (3), Czechia (3), Jordan (3), Puerto Rico (3), Singapore (3), South Africa (3), Georgia (2), Kazakhstan (2), Saudi Arabia (2).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Metabolic Dysfunction Associated Steatohepatitis.

• Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is >18 years
• Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
• Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
• Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to…

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Survodutide; Placebo matching survodutide

Registered summary

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. The full summary is on the listing.

Where, as registered

126 US sites in 25 states; also Japan (55), China (50), United Kingdom (21), Germany (15), France (14), India (12), South Korea (10), Taiwan (10), Argentina (9), Brazil (9), Italy (9), Poland (9), Spain (9), Australia (8), Mexico (8), Turkey (Türkiye) (8), Bulgaria (7), Canada (6), Austria (5), Belgium (4), Hungary (4), Malaysia (4), New Zealand (4), Chile (3), Czechia (3), Netherlands (3), Puerto Rico (3), Singapore (3), Switzerland (3), Georgia (2), Jordan (2), Kazakhstan (2), Romania (2), Saudi Arabia (2), South Africa (2).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Type 2 Diabetes.

• Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
• Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)/European association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C:
• Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol/mol) and <9.5% (<80…
• Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and/or Maximum tolerated dose of sulfonylurea and/or…

5 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Placebo; Survodutide

Registered summary

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. The full summary is on the listing.

Where, as registered

88 US sites in 30 states; also India (13), Canada (10), Australia (4), New Zealand (4), Puerto Rico (1).

Who the trial lists, as registered

Lists people 18 to 55; healthy volunteers accepted. Conditions: Healthy; Obesity.

• Male or female trial participant who is healthy or otherwise healthy with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood…
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 22.0 to 39.9 kg/m\^2 (inclusive)
• Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Survodutide formulation A; Survodutide formulation B2

Registered summary

The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product \[formulation A\]) and in a vial (test product \[formulation B2\]) in male and female trial participants who are healthy or otherwise healthy with overweight/obesity, following subcutaneous administration.

Where, as registered

No US site; Germany (1).

Who the trial lists, as registered

Lists female participants 45 to 65. Conditions: Obesity.

• Signed and dated written informed consent in accordance with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Female (sex assigned at birth) with age >18 years at the time of screening
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• Women of Childbearing Potential (WOCBP) must be ready and able to use at least an acceptable effective contraceptive method of birth control Further inclusion criteria apply.

The exclusion criteria are on the listing.

What it tests, as registered

Survodutide; Placebo

Registered summary

This study is open to women up to 65 years of age who are living with overweight or obesity and are going through or have finished menopause. People can join this study if they have a Body Mass Index (BMI) of 30 kg/m² or more, or if their BMI is 27 kg/m² or more and they have one or more weight related health problems. Participants must also have tried to lose weight by dieting at least once in the past without success. People with pre-existing diabetes cannot take part in this study. The full summary is on the listing.

Where, as registered

13 US sites in 7 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Obesity; Metabolic Dysfunction-associated Steatotic Liver Disease.

• Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
• Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
• Body mass index (BMI) ≥27 kg/m²
• Hepatic steatosis established by imaging (ultrasound or cross sectional), transient elastography, or liver biopsy Further inclusion criteria apply.

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Survodutide; Placebo matching survodutide

Registered summary

This study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD). People can take part if their body mass index (BMI) is 27 kg/m² or higher, and they have certain heart and blood vessel risk factors. The purpose of this study is to find out how a medicine called survodutide affects heart structure and function in people with MASLD. Participants are put into 2 groups randomly, which means by chance. One group gets survodutide as an injection under the skin of the abdomen once a week. The full summary is on the listing.

Where, as registered

13 US sites in 10 states; also United Kingdom (6), Germany (3), China (2), Spain (1).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Obesity.

• Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
• Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control as provided in the protocol Further inclusion criteria apply.

The exclusion criteria are on the listing.

What it tests, as registered

Survodutide

Registered summary

This study is open to adults with overweight or obesity. People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem. Participants must not have diabetes, and they must have tried to lose weight by dieting at least once in the past without success. The purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity lose weight. This study has 2 groups. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Chronic Kidney Disease.

• Age ≥ 18 years
• eGFR ≥20 and <90 mL/min/1.73m2
• Urinary albumin to creatinine ratio >30 mg/g and <3500 mg/g
• BMI >21 kg/m2

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Survodutide (BI 456906); Placebo

Registered summary

The ARTIST-CKD trial is a clinical study evaluating the effect of weekly subcutaneous administration of survodutide (3.6 mg) on kidney function in patients with chronic kidney disease (CKD) and elevated albuminuria. The primary objective is to determine whether survodutide leads to early, sustained, and clinically meaningful reductions in albuminuria, regardless of diabetes status.

Where, as registered

No sites listed yet.