A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Recruiting
Phase 3Interventional Study
ObesityOverweightType 2 Diabetes Mellitus (T2DM)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
This trial is looking for adults who are overweight or have obesity, with or without type 2 diabetes. Participants will take the drug enicepatide while following a diet and exercise program to help manage their weight.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesPancreatitis
You may be able to join if
I have a BMI of 24 or higher if I have type 2 diabetes.
I have a BMI of 28 or higher or a BMI between 24 and 28 with a weight-related health issue if I do not have type 2 diabetes.
I agree to follow the contraception requirements.
You may not be able to join if
I have a history of type 1 diabetes.
I have obesity caused by other hormonal disorders.
I have any planned major surgery during the study.
I have a history of severe mental health issues.
I have ever attempted suicide.
I have any blood conditions that affect lab tests.
I have a history of pancreatitis or gallbladder disease.
I have been treated with GLP-1 receptor therapies in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight wit…
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\^2) for participants with type 2 diabetes mellitus (T2DM)
* BMI ≥28.0 kg/m\^2 or BMI ≥24.0 and \<28.0 kg/m\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatt…
Inclusion Criteria:
* Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\^2) for participants with type 2 diabetes mellitus (T2DM)
* BMI ≥28.0 kg/m\^2 or BMI ≥24.0 and \<28.0 kg/m\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
* Agreement to adhere to the contraception requirements
Exclusion Criteria:
* History of Type 1 diabetes mellitus (T1DM)
* Obesity induced by other endocrinologic disorders
* Any planned major medical procedure or surgery during the study
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
* Any lifetime history of suicide attempt
* History of any hematologic conditions that may interfere with HbA1c measurement
* History of acute or chronic pancreatitis or clinically significant gallbladder disease
* Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
* Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
* Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs
Contacts
Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.