ECC5004 for Type 2 Diabetes

Overseen By Eccogene Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eccogene

Must be taking: Metformin

Must not be taking: Insulin

Disqualifiers: T1DM, MTC, Pancreatitis, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test ECC5004, a new treatment, to determine its safety and effectiveness for individuals who are healthy or have Type 2 Diabetes. The study involves administering different doses of ECC5004 to assess how the body processes it. People with Type 2 Diabetes who manage it with lifestyle changes or metformin (a common diabetes medication) might be suitable candidates. Participants should not be on other diabetes medications and must have stable blood sugar levels.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

If you are taking any non-metformin anti-diabetic medications, you will need to stop them at least 3 months before the study. If you are on a stable dose of metformin, you can continue taking it.

Is there any evidence suggesting that ECC5004 is likely to be safe for humans?

Research shows that ECC5004 is generally well-tolerated in both animals and humans. Previous studies found ECC5004 to be as safe as other similar drugs used for type 2 diabetes. After 28 days of use in humans, ECC5004's safety matched that of these other medications. Participants experienced no major differences in stomach or digestion-related side effects, regardless of food intake. This suggests that ECC5004 is relatively safe, with side effects similar to those of comparable treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ECC5004 is unique because it offers a potential new approach to managing diabetes by exploring a range of doses to optimize its effectiveness and safety. While most diabetes treatments focus on controlling blood sugar levels through insulin or oral medications like metformin, ECC5004 targets a different pathway, which researchers believe could enhance metabolic control. This distinct mechanism of action, combined with the flexibility in dosing, could provide a more tailored treatment option, potentially improving outcomes for both healthy and diabetic individuals.

What evidence suggests that ECC5004 might be an effective treatment for Type 2 Diabetes Mellitus?

Research has shown that ECC5004, which participants in this trial may receive, has yielded promising results in early studies. In the first human trials, ECC5004 did not cause serious side effects, indicating it was well tolerated. It also helped lower blood sugar levels and body weight, offering hope for treating Type 2 Diabetes. ECC5004 interacts with a protein called the GLP-1 receptor, which helps control blood sugar levels. Its safety profile is similar to other treatments targeting this protein. These findings suggest that ECC5004 could effectively manage blood sugar in people with Type 2 Diabetes. ^{1 2 5 6 7}

Who Is on the Research Team?

Eccogene

Principal Investigator

Eccogene Clinical Trials

Are You a Good Fit for This Trial?

Inclusion Criteria

Not taking any active treatment regimen

Healthy male and female participants of non-childbearing potential

BMI of 18.0 to 32.0 kg/m2

Exclusion Criteria

Serum calcitonin > 20 ng/L

Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems

Diagnosis of T1DM or secondary forms of diabetes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Treatment

Participants receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg

Up to 8 days

Multiple visits (in-person)

Multiple Ascending Dose (MAD) Treatment

Participants receive a once-daily dose of ECC5004 ranging from 10 mg to 150 mg for 28 days

28 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 days

What Are the Treatments Tested in This Trial?

Interventions

• ECC5004
• Placebo

How Is the Trial Designed?

Group I: SAD Cohorts 1 to 2: Participants receiving ECC5004 Experimental Treatment 1 Intervention

Participants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.

Group II: MAD Cohorts 1 to 4: Participants receiving ECC5004 Experimental Treatment 1 Intervention

Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses of ECC5004 ranging from 10 mg to 150 mg for 28 days.

Group III: MAD Cohorts 1 to 4: Participants receiving Placebo Placebo Group 1 Intervention

Participants will be randomized to receive a once-daily dose of placebo for 28 days.

Group IV: SAD Cohorts 1 to 2: Participants receiving Placebo Placebo Group 1 Intervention

Participants in each SAD cohort will be randomized to receive placebo.

Who Is Running the Clinical Trial?

Eccogene

Lead Sponsor

Trials

5

Recruited

300+

Citations

1. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16047

Non‐clinical and first‐in‐human characterization of ECC5004 ... In the first-in-human study, ECC5004 was well tolerated with no serious adverse events. Dose-dependent reductions in glucose and body weight ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39495140/

Non-clinical and first-in-human characterization of ... ECC5004 engaged the GLP-1R across the therapeutic dose range tested and had a safety and tolerability profile consistent with other GLP-1 RAs.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05654831

NCT05654831 | FTIH of ECC5004 in Healthy and Diabetic ... This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC5004 in healthy participants

4. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2023/agreement-with-eccogene-for-clinical-stage-glp-1ra.html

AstraZeneca licenses novel agent for the treatment of ... Preliminary results from the Phase I trial have shown a differentiating clinical profile for ECC5004, with good tolerability and encouraging ...

5. synapse.patsnap.com synapse.patsnap.com/article/eccogene-begins-phase-1b-trial-of-azd5004ecc5004-in-china

Eccogene Begins Phase 1b Trial of AZD5004/ECC5004 in ... These studies aim to assess the efficacy and safety of oral, once-daily administration of AZD5004/ECC5004 in individuals dealing with obesity or ...

6. caymanchem.com caymanchem.com/product/41324/ecc5004?srsltid=AfmBOorxozZgeKvvZuW9WolIQmEfma1iA9CvKCgKHa28h-PD5nlTqbuf

ECC5004 (AZD 5004, CAS Number: 3011682-51-9) ECC5004. Item No. 41324. ECC5004 (AZD 5004, CAS Number: 3011682-51-9). Download Product Insert (PDF)Download Safety Data Sheet (SDS) (PDF). 1 mg: $195: In stock ...

7. eccogene.com eccogene.com/wp-content/uploads/OW-2024_ECC5004-Food-Effects-Poster_FINAL_24Oct2024-1.pdf

AZD5004/ECC5004, a Small Molecule GLP-1 Receptor ... Safety and tolerability were in accordance with previous studies6,7 and there was no difference in GI tolerability observed between fed and ...