MBX 2109 for Hypoparathyroidism

Not currently recruiting at 28 trial locations

Overseen By Kristi Schneider, RN, ANP-BC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MBX Biosciences

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MBX 2109 for individuals with hypoparathyroidism, a condition where the body produces too little parathyroid hormone, leading to calcium imbalance. The trial aims to assess the safety and tolerability of MBX 2109 over an extended period. Participants will receive weekly injections of MBX 2109 in varying doses to determine the optimal balance between effectiveness and safety. Those who participated in a previous related study and have had hypoparathyroidism for at least six months may be suitable candidates for this trial. As a Phase 2 trial, this research measures how well MBX 2109 works in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that MBX 2109 is likely to be safe for humans?

Research has shown that MBX 2109 is generally safe for people with hypoparathyroidism. Studies found no serious or severe side effects linked to MBX 2109, indicating that participants did not experience unexpected health issues. This treatment mimics a hormone that regulates calcium levels in the body and has a long-lasting effect, eliminating the need for daily administration. Overall, evidence suggests that MBX 2109 is safe to use, with no unusual safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hypoparathyroidism?

MBX 2109 is unique because it offers a once-weekly subcutaneous injection, potentially simplifying the treatment regimen for hypoparathyroidism compared to the current standard, which often involves multiple daily doses of oral calcium and vitamin D supplements. Researchers are excited about MBX 2109 because it could provide a more consistent and manageable approach to maintaining stable calcium levels, reducing the need for frequent adjustments in medication. Additionally, the wider dosage range in its two experimental arms (200-1600 µg and 400 µg) allows for flexibility and personalization in treatment, which is a significant advantage over more rigid current therapies.

What evidence suggests that MBX 2109 might be an effective treatment for hypoparathyroidism?

Research shows that MBX 2109 can help people with hypoparathyroidism, a condition where the body doesn't produce enough parathyroid hormone. This trial will evaluate MBX 2109 at different doses, specifically 200-1600 µg and 400 µg, administered once weekly by subcutaneous injection. One study found that MBX 2109 increased calcium levels in the blood over time and with varying doses. This indicates the treatment can help control calcium levels, which is crucial for people with hypoparathyroidism. Additionally, 63% of patients responded well to MBX 2109 after 12 weeks, experiencing significant benefits. Early results suggest that MBX 2109 could be a promising treatment for managing this condition. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with hypoparathyroidism (post-surgical, idiopathic, or autoimmune) diagnosed for at least half a year. Participants must have finished a previous 12-week Phase 2 study of MBX-2109 and be able to self-administer the drug after proper demonstration.

Inclusion Criteria

Must have completed the Week 12 Visit in MBX-2H1002 Study

I have been diagnosed with a specific type of low parathyroid hormone for over 6 months.

In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MBX 2109 once weekly to evaluate long-term safety and tolerability

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MBX 2109

Trial Overview The trial tests the long-term safety and tolerability of MBX-2109 in patients with hypoparathyroidism. It involves weekly subcutaneous injections ranging from 200 to 1600 µg, following up on an earlier phase study.

How Is the Trial Designed?

Group I: 400 µg once-weekly by subcutaneous injection Experimental Treatment 1 Intervention

Group II: 200-1600 µg once-weekly by subcutaneous injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

MBX Biosciences

Lead Sponsor

Trials

5

Recruited

290+

Published Research Related to This Trial

After 8 years of treatment with recombinant human parathyroid hormone (1-84), patients with hypoparathyroidism experienced significant reductions in their need for supplemental calcium (57%) and active vitamin D (76%), indicating improved management of their condition.

The therapy was associated with stable renal function and increased bone mineral density (BMD) at the lumbar spine and total hip, demonstrating both safety and efficacy over the long term, with minimal occurrences of hypercalcemia or hypocalcemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of Hypoparathyroidism With rhPTH(1-84): A Prospective, 8-Year Investigation of Efficacy and Safety. Tay, YD., Tabacco, G., Cusano, NE., et al.[2020]

Hypoparathyroidism is relatively common among hospitalized patients in Italy, with a prevalence of 5.3 cases per 100,000 inhabitants per year, and the majority of cases (72.2%) occur in women.

There has been a significant decrease in hospitalization rates for hypoparathyroidism, particularly for postsurgical cases, over the 8-year study period from 2006 to 2013.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Epidemiology of Hypoparathyroidism in Italy: An 8-Year Register-Based Study. Cipriani, C., Pepe, J., Biamonte, F., et al.[2018]

Hypoparathyroidism, often caused by thyroid surgery, leads to low calcium and high phosphorus levels, and current treatments focus on calcium and vitamin D supplementation to maintain serum calcium in the low-normal range.

Recombinant human PTH 1-84 is now available as a hormone replacement therapy for patients who do not respond well to standard treatments, marking a significant advancement in managing this rare endocrine disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Hypoparathyroidism. Abate, EG., Clarke, BL.[2019]

Patients with hypoparathyroidism, despite receiving standard treatment with calcium and vitamin D, report a significantly reduced quality of life compared to norm-based populations, indicating that the absence of parathyroid hormone may directly affect their well-being.

A systematic review of five studies found that hypoparathyroidism patients experience various physical, mental, and emotional symptoms, highlighting the need for further research to better understand and quantify these impacts on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with hypoparathyroidism receiving standard treatment: a systematic review. Büttner, M., Musholt, TJ., Singer, S.[2018]

A consensus was reached among Delphi panels in the UK, Sweden, and Portugal on key characteristics that define chronic hypoparathyroidism as inadequately controlled, focusing on patient characteristics, comorbidities, biochemistry, and symptoms affecting quality of life.

Important factors identified include compliance issues, chronic kidney disease stages 4 and 5, and specific biochemical parameters like serum calcium and urinary calcium, which should be further evaluated for their relevance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Characteristics of Chronic Hypoparathyroidism Not Adequately Controlled on Conventional Therapy: Consensus Findings of Three European Delphi Panels. Iqbal, K., Dass, N., Gip, C., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11913096/

MBX 2109, A Once-Weekly Parathyroid Hormone ... A dose- and time-dependent increase in the maximal serum calcium response and decrease in endogenous PTH(1-84) levels were seen with MBX 2109 treatment. In ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06465108

Safety, Pharmacokinetics and Efficacy of MBX 2109 in ... This study is to investigate the safety, pharmacokinetics, and efficacy of MBX 2109 administered once weekly to patients with hypoparathyroidism.

3. investors.mbxbio.com investors.mbxbio.com/news-releases/news-release-details/mbx-biosciences-announces-once-weekly-canvuparatide-achieved

MBX Biosciences Announces Once-Weekly Canvuparatide ... MBX Biosciences Announces Once-Weekly Canvuparatide Achieved Primary Endpoint in Phase 2 Trial with 63% Responder Rate at 12 Weeks; 79% ...

4. academic.oup.com academic.oup.com/jcem/article-abstract/110/4/940/7906730

MBX 2109, A Once-Weekly Parathyroid Hormone ... Treatment-emergent adverse events (TEAEs) occurred in 50% to 88% of MBX 2109 groups and in 25% of placebo participants. In the MBX 2109 groups, no severe or ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/mbx-biosciences-hypoparathyroidism-trial/

MBX Biosciences dosing subjects in hypoparathyroidism ... MBX Biosciences has dosed the first subject in a Phase II trial of MBX 2109, a potential treatment for chronic hypoparathyroidism (HP).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39574220/

MBX 2109, A Once-Weekly Parathyroid Hormone ... Conclusion: The sustained-action PTH prodrug MBX 2109 was well tolerated with no unexpected, off-target safety issues. The long half-life and ...

7. academic.oup.com academic.oup.com/jcem/article/110/4/940/7906730

MBX 2109, A Once-Weekly Parathyroid Hormone ... The sustained-action PTH prodrug MBX 2109 was well tolerated with no unexpected, off-target safety issues. The long half-life and flat exposure profile of MBX ...

8. hypopara.org hypopara.org/news-events/news/mbx-biosciences-announces-mbx-2109-phase-1-study-results

MBX Biosciences announces mbx-2109 phase 1 study ... No MBX 2109 dose-related serious or severe adverse events or deaths were reported. About Hypoparathyroidism HP is a rare endocrine disease ...