Enicepatide for Obesity and Type 2 Diabetes

(Enith2 Trial)

Recruiting at 35 trial locations

Overseen By Reference Study ID Number: WC45726 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must be taking: Oral anti-hyperglycemics

Must not be taking: DPP-4 inhibitors, GLP-1 RAs

Disqualifiers: Type 1 diabetes, Severe hypoglycemia, Poorly controlled hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called enicepatide to determine its effectiveness in aiding weight loss and managing Type 2 diabetes. Enicepatide targets hormones that regulate appetite and insulin. The study will compare various doses with a placebo. Suitable participants have Type 2 diabetes, are overweight, have unsuccessfully tried to lose weight through diet and exercise, and are willing to self-administer the study drug. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that enicepatide is likely to be safe for humans?

Research has shown that enicepatide, a medication targeting specific receptors in the body, has been studied for safety and effectiveness in individuals with obesity and type 2 diabetes. Previous studies found that enicepatide is generally well-tolerated, with most side effects being mild, such as nausea or diarrhea.

Detailed data from past studies support its safety, with no serious side effects commonly linked to the treatment. These findings suggest that enicepatide could be a safe option for managing weight in people with these conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity and Type 2 diabetes?

Enicepatide is unique because it offers a new approach to treating obesity and type 2 diabetes by potentially targeting different pathways compared to standard treatments like metformin, GLP-1 receptor agonists, and SGLT2 inhibitors. Researchers are excited about Enicepatide because it consists of a novel peptide that might improve insulin sensitivity and promote weight loss more effectively. Unlike current options, which often require daily administration, Enicepatide's dosing regimens could provide more flexibility and convenience for users. This could lead to better adherence and overall outcomes for patients struggling with these conditions.

What evidence suggests that this trial's treatments could be effective for obesity and Type 2 diabetes?

Research shows that enicepatide, a new treatment under investigation in this trial, may help manage obesity and Type 2 diabetes. Similar treatments, such as tirzepatide, have lowered blood sugar levels by up to 2.07% and led to significant weight loss. In studies, patients lost more than 10% of their body weight, a major achievement for those struggling with obesity. Enicepatide has also been linked to double-digit weight loss over time, indicating its potential effectiveness. These findings suggest that enicepatide could aid in weight management and blood sugar control for people with obesity and Type 2 diabetes. Participants in this trial will receive different dosing regimens of enicepatide or a placebo to evaluate its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

Inclusion Criteria

History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

I am able and willing to give myself the study drug or have someone trained do it for me.

Body mass index (BMI) ≥27.0 kg/m^2

Exclusion Criteria

I have had type 1 diabetes or serious diabetic complications.

My weight has changed by more than 5 kg in the last 3 months.

Confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) on 2 non-consecutive days during screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enicepatide or placebo for weight management

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enicepatide

How Is the Trial Designed?

Group I: Arm 4: Enicepatide Dosing Regimen 3 Experimental Treatment 1 Intervention

Group II: Arm 3: Enicepatide Dosing Regimen 2 Experimental Treatment 1 Intervention

Group III: Arm 2: Enicepatide Dosing Regimen 1 Experimental Treatment 1 Intervention

Group IV: Arm 1: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06628362

NCT06628362 | A Study of Enicepatide (CT-388) in ...

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10088547/

Efficacy and Safety of Tirzepatide in Type 2 Diabetes ... - PMC

In people with early T2DM treated only with diet and exercise (SURPASS-1), tirzepatide 5 to 15 mg improved the HbA1c by 1.87% to 2.07% compared to 0.04% ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07351058

NCT07351058 | A Clinical Study to Evaluate the Effects of ...

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 ...

4.

clinicaltrial.be

clinicaltrial.be/en/details/444472?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study of Enicepatide (CT-388) in Participants With Obes...

Secondary outcomes 15 · Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 · Absolute Change in Body ...

5.

forpatients.roche.com

forpatients.roche.com/en/trials/metabolic-disorder/obesity/a-study-of-ct-388-in-participants-who-are-overweight-or-91515.html

Clinical Study | CT-388 RO7795068 - ForPatients - Roche

It is being developed to treat people living with obesity or overweight with or without Type 2 diabetes. CT-388 is an experimental medicine. This means health ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-clinical-study-to-evaluate-the-effects-of-ro7795068-in-participants-with-obesity-or-overweight-and

A Clinical Study to Evaluate the Effects of Enicepatide ...

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent ...