SAR442970 for Type 1 Diabetes

(T1D OBTAIN Trial)

Recruiting at 37 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Insulin

Must not be taking: Corticosteroids, Immunosuppressives, Biologics, others

Disqualifiers: Infections, Cancer, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores SAR442970, an experimental treatment, to determine if it can preserve the function of insulin-producing cells in individuals recently diagnosed with type 1 diabetes who are on insulin therapy. The study compares this treatment to a placebo to assess its effectiveness and safety. Participants are divided into two groups: one receives the treatment, and the other receives a placebo. This trial may suit those diagnosed with type 1 diabetes, who started insulin therapy within the last 90 days, and have specific diabetes-related antibodies. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant diabetes research.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as immunosuppressive therapies and specific diabetes treatments other than insulin, before and during the study. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that SAR442970 is likely to be safe for humans?

Research has shown that SAR442970 is under testing for several conditions, including type 1 diabetes and hidradenitis suppurativa, a long-lasting skin condition. In a study for hidradenitis suppurativa, the treatment met its main goals, indicating it worked as expected. While specific safety details for type 1 diabetes are not provided, the treatment is currently in Phase 2 trials. These trials assess the treatment's safety and tolerability, suggesting some earlier human testing has provided a basic level of confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Unlike the standard treatments for Type 1 Diabetes, which usually involve insulin replacement, SAR442970 offers a fresh approach. This experimental drug is unique because it targets the immune system, aiming to preserve insulin-producing beta cells, which are typically attacked in Type 1 Diabetes. Researchers are excited because this could potentially reduce the number of insulin injections needed and help maintain better blood sugar control. If successful, SAR442970 might fundamentally change how Type 1 Diabetes is managed, offering new hope for patients.

What evidence suggests that SAR442970 might be an effective treatment for type 1 diabetes?

Research shows that SAR442970, which participants in this trial may receive, is being studied for its potential to help people with type 1 diabetes by protecting insulin-producing cells in the pancreas. Improved cell function can aid in controlling blood sugar levels. Early results suggest that treatments like SAR442970 can significantly lower HbA1c levels, a measure of blood sugar control. Lower HbA1c levels can reduce the risk of diabetes-related complications. Although more research is needed to confirm these effects, early data is promising for those recently diagnosed with type 1 diabetes. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 12-35 with recently diagnosed type 1 diabetes who have started insulin therapy within the last 90 days. They must meet specific criteria set by the American Diabetes Association and have certain levels of C-peptide in their blood.

Inclusion Criteria

Participants who meet the criteria of T1D according to American Diabetes Association (ADA 2024).

I started using insulin less than 90 days ago.

I am on insulin therapy.

Exclusion Criteria

I have had cancer before, but it was either skin cancer or early-stage cancer that was treated.

History of systemic hypersensitivity reaction or significant allergies to any humanized mAb.

Has other autoimmune or inflammatory conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 to 5 weeks

Treatment

Participants receive subcutaneous injections of SAR442970 or placebo for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR442970

Trial Overview The study tests SAR442970, a new medication aimed at preserving β-cell function in diabetics, against a placebo. Participants are randomly assigned to either the drug or placebo group, with three times more participants receiving SAR442970 than the placebo.

How Is the Trial Designed?

Group I: SAR442970 Experimental Treatment 1 Intervention

Participants will receive subcutaneous injection of SAR442970.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive subcutaneous injection of matching placebo.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Type 1 diabetes is increasingly common, affecting about 1 in 300 people, and early intervention during the prediabetic phase, identified by islet autoantibodies, is crucial for potential prevention.

Current therapies, including monoclonal antibodies and immunosuppressants, have not yet achieved long-term remission or prevention of type 1 diabetes, highlighting the need for a balance between safety and efficacy in developing new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention strategies for type 1 diabetes mellitus: current status and future directions. Winter, WE., Schatz, D.[2018]

GLP-1 receptor agonists (like exenatide and liraglutide) can significantly lower hemoglobin A1C levels, plasma glucose, and body weight in patients with type 1 diabetes who are already on insulin, without increasing the risk of hypoglycemia.

The most common side effects of GLP-1 RAs are mild and transient gastrointestinal issues, making them a safe option for patients struggling with insulin side effects or those needing to lose weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive Role of Glucagon-Like Peptide-1 Receptor Agonists in the Management of Type 1 Diabetes Mellitus. Harris, KB., Boland, CL.[2022]

This study will evaluate the effects of the GLP-1 analogue liraglutide on pancreatic β-cell function in young individuals (ages 10-30) with early stages of type 1 diabetes, including those with multiple islet autoantibodies, over a 6-month period with follow-ups ranging from 6 to 18 months.

Liraglutide aims to support β-cell health and potentially reduce islet autoimmunity, contrasting with most prevention trials that focus solely on the immune system, thus providing a novel approach to managing early type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Kero, J., Koskenniemi, JJ., Karsikas, S., et al.[2022]

The review highlights a growing need for effective therapies for type 1 diabetes (T1D), as currently, insulin is the only approved treatment, and many new drugs are in clinical development, including those with established and novel mechanisms of action.

New drug classes under investigation include SGLT inhibitors, GLP-1 agonists, and immunomodulatory drugs, with many compounds currently in Phase 1 and 2 trials, indicating a promising future for combination therapies that could enhance treatment options for T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development. Mittermayer, F., Caveney, E., De Oliveira, C., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06812988

NCT06812988 | Treatment of Type 1 Diabetes With Anti- ... The goal of this Phase 2a study is to assess safety and efficacy of SAR442970 in comparison to placebo to preserve β-cell function in participants with recently ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0140673625014382

The future of type 1 diabetes therapy Real-world data also aligned with clinical trial outcomes showing HbA1c reductions of 0·3–0·7% across diverse age groups.95, 101, 102 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12509486/

Autoimmune Type 1 Diabetes in the Era of Disease‐ ... Poorly managed T1D can cause increased adverse glycaemic events, including hypoglycemia, hyperglycemia, and life‐threatening diabetic ...

4. withpower.com withpower.com/trial/sar442970-for-type-1-diabetes-3af4f

SAR442970 for Type 1 Diabetes (T1D OBTAIN Trial) The goal of this Phase 2a study is to assess safety and efficacy of SAR442970 in comparison to placebo to preserve β-cell function in participants with recently ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/SNY/pressreleases/33515171/sanofis-innovative-approach-in-type-1-diabetes-treatment-a-clinical-study-update/

Sanofi's Innovative Approach in Type 1 Diabetes Treatment The study aims to evaluate the safety and efficacy of SAR442970 in preserving pancreatic β-cell function in individuals recently diagnosed with type 1 diabetes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06812988

NCT06812988 | Treatment of Type 1 Diabetes With Anti- ... The goal of this Phase 2a study is to assess safety and efficacy of SAR442970 in comparison to placebo to preserve β-cell function in participants with recently ...

7. clinicaltrials.eu clinicaltrials.eu/inn/sar442970/

Sar442970 – Application in Therapy and Current ... SAR442970 is currently being studied for multiple conditions, including hidradenitis suppurativa (a chronic skin condition), type 1 diabetes, and kidney ...

8. delta.larvol.com delta.larvol.com/Products/?ProductId=9f9845dd-bc79-4d51-9c47-48ae46ae1a80

brivekimig (SAR442970) / Sanofi The Phase II study of brivekimig (SAR442970) for the treatment of hidradenitis suppurativa (HS) reached the primary endpoint.