CT-388 for Type 2 Diabetes and Obesity

Not currently recruiting at 93 trial locations

Overseen By Reference Study ID: CT-388-104 Roche Study ID: XC45544

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Carmot Therapeutics, Inc.

Must be taking: Metformin, SGLT-2 inhibitors

Must not be taking: Oral antihyperglycemics, Injectable antihyperglycemics

Disqualifiers: Type 1 diabetes, Retinopathy, Neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CT-388 (also known as RG-6640) to evaluate its effectiveness and safety for individuals with Type 2 diabetes who are overweight or obese. Participants will receive one of several doses of CT-388 or a placebo (a substance with no active drug) to determine the most effective dose. The trial aims to help manage blood sugar levels and support weight loss in those with Type 2 diabetes. Suitable candidates have been managing their diabetes with diet, exercise, or specific medications but have struggled to lose weight. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You can continue taking metformin or SGLT-2 inhibitors for managing Type 2 diabetes, but you cannot take other oral or injectable diabetes medications during the study.

Is there any evidence suggesting that CT-388 is likely to be safe for humans?

Previous studies have shown promising safety results for CT-388. Research indicates that participants tolerated this once-weekly injection well. Reports from these studies highlight significant weight loss, with participants experiencing more than an 8% reduction in weight, without major safety issues. This suggests that CT-388 might be a safe option for people dealing with obesity and Type 2 diabetes. While some side effects can occur with any treatment, the data so far supports its safety in humans. ^{1 2 3 4 5}

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

CT-388 is unique because it potentially offers a new way to tackle both type 2 diabetes and obesity by targeting metabolic pathways differently than current standard treatments like metformin or GLP-1 receptor agonists. Researchers are excited because CT-388 may improve insulin sensitivity and help with weight management simultaneously, which can be transformative for patients dealing with both conditions. Additionally, the different dosing levels being tested could allow for more personalized treatment options, tailoring the therapy to individual needs for better outcomes.

What evidence suggests that CT-388 could be an effective treatment for Type 2 diabetes and obesity?

Research has shown that CT-388, a new treatment under study in this trial, offers promising results for people with Type 2 diabetes and obesity. Studies found that a once-a-week injection of CT-388 led to significant weight loss, aiding in better diabetes management. This treatment works by targeting specific receptors that control blood sugar and appetite. Previous trials reported that CT-388 not only facilitated weight loss but also improved overall metabolic health. The treatment is well-tolerated, with most participants handling it well. Participants in this trial will receive varying doses of CT-388 or a placebo to further evaluate its effectiveness and safety. ^{3 4 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Carmot Therapeutics, Inc., a Member of the Roche Group

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who are overweight or obese with Type 2 diabetes. They should have tried diet and exercise without success, have an HbA1c level between 7% and 10.5%, and a BMI of at least 25 kg/m^2. Participants may be managing their diabetes with diet, exercise, metformin, or SGLT-2 inhibitors.

Inclusion Criteria

Body mass index (BMI) ≥25.0 kg/m^2

At least one self-reported unsuccessful diet/exercise effort to lose body weight

HbA1c ≥7% and ≤10.5%

Exclusion Criteria

I have had pancreatitis before.

I am currently experiencing symptoms of nerve damage.

I have been diagnosed with major depressive disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly subcutaneous administration of CT-388 or placebo for 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CT-388

Trial Overview The study tests the effectiveness and safety of CT-388 in three different doses compared to a placebo in controlling blood sugar levels for those with obesity and Type 2 diabetes. It's randomized (participants are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), and placebo-controlled.

How Is the Trial Designed?

Group I: Arm 5: CT-388 Dose Level 4 (High) Experimental Treatment 1 Intervention

Group II: Arm 4: CT-388 Dose Level 3 Experimental Treatment 1 Intervention

Group III: Arm 3: CT-388 Dose Level 2 Experimental Treatment 1 Intervention

Group IV: Arm 2: CT-388 Dose Level 1 (Low) Experimental Treatment 1 Intervention

Group V: Arm 1: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Carmot Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

1,300+

Hoffmann-La Roche

Industry 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/NCT06525935

NCT06525935 | A Study of CT-388 in Participants With ... This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/72/Supplement_1/75-LB/149193/75-LB-CT-388-a-Novel-Once-Weekly-Dual-GLP-1-and

75-LB: CT-388, a Novel Once-Weekly Dual GLP-1 and GIP ... In summary, CT-388 delivers clinically meaningful weight loss and metabolic control with a favorable tolerability profile. These data warrant ...

3. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/metabolic-disorder/obesity/a-study-of-ct-388-in-participants-who-are-overweight-or-91515.pdf

A study of CT-388 in participants living with obesity or ... Weight loss can improve health, reduce the risk or seriousness of other health problems, or even reverse the symptoms of Type 2 diabetes. But it can be ...

4. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/roche-s-novel-dual-glp-1-gip-receptor-agonist-produces-clinically-meaningful-weight-loss-in-phase-ib-trial

Roche's Novel Dual GLP-1/GIP Receptor Agonist Produces ... Once-weekly subcutaneous injection of CT-388 produced significant weight loss in healthy adults with obesity compared with placebo across 24 ...

5. gene.com gene.com/media/press-releases/15024/2024-05-15/genentech-reports-positive-phase-ib-resu

Genentech: Press Releases | Wednesday, May 15, 2024 The study found that a once-weekly subcutaneous injection of CT-388 over 24 weeks resulted in significant weight loss in healthy adults with obesity compared ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06525935

NCT06525935 | A Study of CT-388 in Participants With ... This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388.

7. genentech-clinicaltrials.com genentech-clinicaltrials.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 Access the clinical study evaluating the efficacy, safety and tolerability of once-weekly CT-388 administered subcutaneously for 48 weeks to participants ...

8. clinicaltrial.be clinicaltrial.be/en/details/453714?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study of CT-388 in Participants Who Are Overweight or O... This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, ...