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Peptide

Treatment arm for Obesity

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 at baseline, at week 48

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ at baseline, at week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, at week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relative change (%) in body weight from baseline to Week 48

Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)

Secondary outcome measures

Absolute change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF

Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5)

Absolute change from baseline to Week 48 in alanine amino transferase (ALT) levels

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment armExperimental Treatment1 Intervention

Group II: Placebo armPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,747 Total Patients Enrolled

19 Trials studying Obesity

9,627 Patients Enrolled for Obesity

Frequently Asked Questions

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

Is this clinical trial currently open for enrollment?

"Affirmative. Records from clinicaltrials.gov indicate that this medical investigation is presently in search of eligible participants. The trial was originally listed on March 13th, 2024, with the most recent update made on April 2nd, 2024. The aim is to recruit a total of 160 patients from one designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical trial?

"Affirmative. Information from clinicaltrials.gov indicates that this medical trial is actively seeking participants. The trial was initially posted on March 13, 2024 and last updated on April 2, 2024. It aims to enroll a total of 160 individuals at one site."

Answered by AI

Has the treatment arm obtained approval from the FDA?

"Our expert team at Power has assigned a safety rating of 3 to the Treatment arm, reflecting the comprehensive safety data gathered during this Phase 3 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight

2024. "A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06309992.

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