Type 1 Diabetes MellitusPhase 1NCT05272059
Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus
A Phase 1 study testing MHS552 in people with Type 1 Diabetes Mellitus, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus. Participants will be treated for 4 or 12 weeks followed by an 8 week follow-up period Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- MHS552
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 14 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult men and women ages 18 to 45, inclusive, body weight between ≥40 to ≤150 kg, inclusive, with T1DM, a maximum of 5 years from T1DM diagnosis at screening.
- Evidence of one or more T1DM autoantibody(ies) including glutamic acid decarboxylase (anti GAD), protein tyrosine, phosphatase-like protein (anti-IA-2); zinc transporter 8 (anti-ZnT8); islet cell (cytoplasmic) (anti-ICA)
- Residual pancreatic β-cell function (fasting C-peptide >100 pmol/L [0.30 ng/mL] or random C peptide >200 pmol/L [0.60 ng/mL])
Who cannot join
- History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or immunoglobulin (IgG1) proteins, hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.
- Use of other investigational drugs or use of immunosuppressive agents at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Diabetes forms other than autoimmune type 1 such as maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), acquired diabetes (secondary to medications or surgery), type 2 diabetes by judgement of the investigator.
- Diabetic ketoacidosis within 2 weeks.
- Polyglandular auto-immune disease, including but not limited to: Addison's disease, pernicious anemia, celiac sprue and psoriasis. Treated, stable Hashimoto's thyroiditis is not exclusionary.
- History of capillary leak syndrome (CLS).
- Ongoing, and up to 2 weeks prior to screening, initiation of medications or change in dose of medications that may affect glucose control (e.g, systemic steroids, thiazides, beta blockers).
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Randomized, Investigator and Participant Blinded, Placebo Controlled, Multiple Ascending Dose, Two Part Design Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of MHS552 in Adults With Type 1 Diabetes Mellitus (T1DM)
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus. Participants will be treated for 4 or 12 weeks followed by an 8 week follow-up period
Read the detailed description
This is a Phase 1b, randomized, investigator and participant blinded, placebo controlled, multiple ascending dose (MAD) study in adults with type 1 diabetes mellitus (adults aged 18-45 years, inclusive, diagnosed with T1DM within 5 years at the time of screening). This MAD study will be conducted in two sequential parts, Part A and Part B.
In Part A, after an screening period of up to 28 days, participants will be randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A will consist of up to 3 cohorts (low, medium, high dose), with approximately 4-8 participants completing each cohort (total of approximately 16 participants). Participants will be followed-up during 8 weeks post last dose. The total duration of study participation of Part A is approximately 106 Days.
In Part B, after a screening period of up to 28 days, approximately 12 participants will be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose level 4). Participants will be followed-up during 8 weeks post last dose with End of Study (EoS) visit at Day 134. The total duration of study participation of Part B is approximately 162 Days.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- MHS552, Placebo
- Keywords
- type 1 diabetes mellitus, T1DM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHS552Drug
MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
PlaceboDrug
Placebo will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1 - MHS552 low dose | Experimental | Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks Receives: Drug: MHS552 |
| Part A: Cohort 1, 2, 3 - Placebo | Placebo comparator | Participants will receive placebo once weekly subcutaneously for 4 weeks Receives: Drug: Placebo |
| Part A: Cohort 2 - MHS552 medium dose | Experimental | Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks Receives: Drug: MHS552 |
| Part A: Cohort 3 - MHS552 high dose | Experimental | Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks Receives: Drug: MHS552 |
| Part B: MHS552 | Experimental | Participants will MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks Receives: Drug: MHS552 |
| Part B: Placebo | Placebo comparator | Participants will receive placebo once weekly subcutaneously for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Numbers of participants with AEs and SAEs including vital signs, electrocardiograms (ECG) and laboratory results
Measured: Part A: up to 12 weeks; Part B: up to 20 weeks
Secondary outcomes (3)
Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552
Characterize the AUCtau profile following multiple doses of MHS552
Measured: Part A: up to Day 78; Part B: up to Day 134
Maximum ObservBlood Concentrations (Cmax) for MHS552
Characterize the Cmax profile following multiple doses of MHS552
Measured: Part A: up to Day 78; Part B: up to Day 134
Time to Reach Maximum Blood Concentrations (Tmax) of MHS552
Characterize the Tmax profile following multiple doses of MHS552
Measured: Part A: up to Day 78; Part B: up to Day 134
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Sep 2023 (estimated)
- Primary completion14 Apr 2025 (estimated)
- Study completion14 Apr 2025 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272059
- Sponsor's protocol ID
- CMHS552B12101
- Status last verified
- Apr 2023
- First submitted
- 28 Feb 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator and Participant Blinded, Placebo Controlled, Multiple Ascending Dose, Two Part Design Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of MHS552 in Adults With Type 1 Diabetes Mellitus (T1DM)
- ClinicalTrials.gov ID
- NCT05272059
- Acronym / sponsor ID
- CMHS552B12101
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, T1DM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 14 Apr 2025 (estimated)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus. Participants will be treated for 4 or 12 weeks followed by an 8 week follow-up period
Detailed description
This is a Phase 1b, randomized, investigator and participant blinded, placebo controlled, multiple ascending dose (MAD) study in adults with type 1 diabetes mellitus (adults aged 18-45 years, inclusive, diagnosed with T1DM within 5 years at the time of screening). This MAD study will be conducted in two sequential parts, Part A and Part B.
In Part A, after an screening period of up to 28 days, participants will be randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A will consist of up to 3 cohorts (low, medium, high dose), with approximately 4-8 participants completing each cohort (total of approximately 16 participants). Participants will be followed-up during 8 weeks post last dose. The total duration of study participation of Part A is approximately 106 Days.
In Part B, after a screening period of up to 28 days, approximately 12 participants will be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose level 4). Participants will be followed-up during 8 weeks post last dose with End of Study (EoS) visit at Day 134. The total duration of study participation of Part B is approximately 162 Days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1 - MHS552 low dose | Experimental | Drug: MHS552Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks |
| Part A: Cohort 1, 2, 3 - Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo once weekly subcutaneously for 4 weeks |
| Part A: Cohort 2 - MHS552 medium dose | Experimental | Drug: MHS552Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks |
| Part A: Cohort 3 - MHS552 high dose | Experimental | Drug: MHS552Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks |
| Part B: MHS552 | Experimental | Drug: MHS552Participants will MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo once weekly subcutaneously for 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult men and women ages 18 to 45, inclusive, body weight between ≥40 to ≤150 kg, inclusive, with T1DM, a maximum of 5 years from T1DM diagnosis at screening.
- Evidence of one or more T1DM autoantibody(ies) including glutamic acid decarboxylase (anti GAD), protein tyrosine, phosphatase-like protein (anti-IA-2); zinc transporter 8 (anti-ZnT8); islet cell (cytoplasmic) (anti-ICA)
- Residual pancreatic β-cell function (fasting C-peptide >100 pmol/L [0.30 ng/mL] or random C peptide >200 pmol/L [0.60 ng/mL])
Key exclusion criteria (8 listed)
- History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or immunoglobulin (IgG1) proteins, hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.
- Use of other investigational drugs or use of immunosuppressive agents at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Diabetes forms other than autoimmune type 1 such as maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), acquired diabetes (secondary to medications or surgery), type 2 diabetes by judgement of the investigator.
- Diabetic ketoacidosis within 2 weeks.
- Polyglandular auto-immune disease, including but not limited to: Addison's disease, pernicious anemia, celiac sprue and psoriasis. Treated, stable Hashimoto's thyroiditis is not exclusionary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHS552MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B) | Drug | Part A: Cohort 1 - MHS552 low dose, Part A: Cohort 2 - MHS552 medium dose, Part A: Cohort 3 - MHS552 high dose, Part B: MHS552 |
| PlaceboPlacebo will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B) | Drug | Part A: Cohort 1, 2, 3 - Placebo, Part B: Placebo |
Primary outcome
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time frame: Part A: up to 12 weeks; Part B: up to 20 weeks
Numbers of participants with AEs and SAEs including vital signs, electrocardiograms (ECG) and laboratory results
3 secondary outcomes
Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Maximum ObservBlood Concentrations (Cmax) for MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Time to Reach Maximum Blood Concentrations (Tmax) of MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MHS552 in people with Type 1 Diabetes Mellitus, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (time frame: Part A: up to 12 weeks; Part B: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.