ObesityPhase 2NCT05199090

Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM

A Phase 2 study testing MBL949 in people with Obesity, run by Novartis Pharmaceuticals at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Obesity
What is being tested?: MBL949
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 126 participants
Where: 4 sitesUnited States
Study dates: 10 Feb 2022to 11 May 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Body mass index: ≥ 32 kg/m2, weight ≥ 77 kg, stable body weight i.e., less than 1.5 kg self-reported change within 90 days
Diagnosed T2DM as documented by medical history and confirmed by Investigator and with diagnosed duration < 10 yrs, HbA1c ≤ 9%, and fasting C-peptide ≥ 0.2 ng/ml
If treated for T2DM, treatment must be limited to diet and exercise and treatment with one of the following anti-diabetic agents (stable for 90 days prior to randomization):
Metformin
SGLT2i inhibitors (if prescribed as the first line, ie. single agent)
DDP4 inhibitors
Acarbose

Who cannot join

Vitals at screening:
systolic blood pressure less than 95 mm Hg or greater than 155 mm Hg
diastolic blood pressure less than 60 mg Hg or greater than 95 mm Hg
pulse rate less than 56 or greater than 110 bpm
History of bariatric surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, gastric banding, and any other intrabdominal procedures designed for weight loss at screening
History of myocardial infarction with 2 years of screening
Diet attempts within 90 days before screening
Participation in organized weight reduction program within 6 months of screening

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Knoxville, Tennessee, 37920
Novartis Investigative Site
Miami, Florida, 33135
Novartis Investigative Site
Morehead City, North Carolina, 28557

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Participant-and-investigator- Blinded, Sponsor Open-label Study to Evaluate the Safety, Tolerability, and Efficacy With Different Dosing Regimens of Subcutaneously Administered MBL949 in Obese Participants With or Without Type 2 Diabetes Mellitus

This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.

Read the detailed description

The study comprised a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants were administered MBL949 or placebo at 8 biweekly intervals starting on Day 1 and a 10-week follow-up period.

Participants were to be enrolled to:

MBL949 Arm 1, MBL949 Arm 2 and placebo in a 1:1:1 ratio
MBL949 Arm 3, MBL949 Arm 4 and placebo in a 1:1:1 ratio
If MBL949 Arm 1 was tolerated, MBL949 Arm 5 was enrolled with a 2:1 ratio (MBL:placebo) within each stratum.

Conditions: Obesity
Being tested: MBL949, Placebo
Keywords: Type 2 diabetes mellitus, weight loss
Medical subject headings: Obesity, Diabetes Mellitus, Type 2, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MBL949Drug
subcutaneous injections administered for 14 weeks
PlaceboDrug
Placebo Comparator to MLB949

Study groups in NCT05199090
Study group	Role	What they receive
MBL949 Arm 1	Active comparator	MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg Receives: Drug: MBL949
MBL949 Arm 2	Active comparator	MBL949 two 3 mg doses followed by six doses of 4.5 mg Receives: Drug: MBL949
MBL949 Arm 3	Active comparator	MBL949 one 12 mg dose followed by seven doses of 4.5 mg Receives: Drug: MBL949
MBL949 Arm 4	Active comparator	MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg Receives: Drug: MBL949
MBL949 Arm 5	Active comparator	MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg Receives: Drug: MBL949
Placebo	Placebo comparator	Placebo to MBL949 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency and Severity of Adverse Events
Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
Measured: Baseline to Day 169
Change-from-baseline in Weight
Baseline weight is defined as the last weight measurement before dosing in kilograms
Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202211 May 2023

First posted20 Jan 2022
Study start10 Feb 2022
Primary completion11 May 2023
Study completion11 May 2023

Why it stopped: The tolerability to benefit ratio based on maximum weight loss observed was not considered favorable at the doses studied and the study was terminated early

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05199090
Sponsor's protocol ID: CMBL949A12201
Other IDs: 2021-004449-19
Status last verified: Oct 2024
First submitted: 17 Dec 2021
Last updated: 9 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Participant-and-investigator- Blinded, Sponsor Open-label Study to Evaluate the Safety, Tolerability, and Efficacy With Different Dosing Regimens of Subcutaneously Administered MBL949 in Obese Participants With or Without Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT05199090
Acronym / sponsor ID: CMBL949A12201
Conditions: Obesity
Keywords: Type 2 diabetes mellitus, weight loss
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The tolerability to benefit ratio based on maximum weight loss observed was not considered favorable at the doses studied and the study was terminated early
Enrolment: 126 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 10 Feb 2022 (actual)
Primary completion: 11 May 2023 (actual)
Study completion: 11 May 2023 (actual)
First posted: 20 Jan 2022 (actual)
Results: Posted 31 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.

Detailed description

Participants were to be enrolled to:

MBL949 Arm 1, MBL949 Arm 2 and placebo in a 1:1:1 ratio
MBL949 Arm 3, MBL949 Arm 4 and placebo in a 1:1:1 ratio
If MBL949 Arm 1 was tolerated, MBL949 Arm 5 was enrolled with a 2:1 ratio (MBL:placebo) within each stratum.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
MBL949 Arm 1	Active comparator	Drug: MBL949MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
MBL949 Arm 2	Active comparator	Drug: MBL949MBL949 two 3 mg doses followed by six doses of 4.5 mg
MBL949 Arm 3	Active comparator	Drug: MBL949MBL949 one 12 mg dose followed by seven doses of 4.5 mg
MBL949 Arm 4	Active comparator	Drug: MBL949MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
MBL949 Arm 5	Active comparator	Drug: MBL949MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo to MBL949

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Body mass index: ≥ 32 kg/m2, weight ≥ 77 kg, stable body weight i.e., less than 1.5 kg self-reported change within 90 days
Diagnosed T2DM as documented by medical history and confirmed by Investigator and with diagnosed duration < 10 yrs, HbA1c ≤ 9%, and fasting C-peptide ≥ 0.2 ng/ml
If treated for T2DM, treatment must be limited to diet and exercise and treatment with one of the following anti-diabetic agents (stable for 90 days prior to randomization):

Key exclusion criteria (8 listed)

Vitals at screening:
History of bariatric surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, gastric banding, and any other intrabdominal procedures designed for weight loss at screening
History of myocardial infarction with 2 years of screening
Diet attempts within 90 days before screening
Participation in organized weight reduction program within 6 months of screening

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
MBL949subcutaneous injections administered for 14 weeks	Drug	MBL949 Arm 1, MBL949 Arm 2, MBL949 Arm 3, MBL949 Arm 4, MBL949 Arm 5
PlaceboPlacebo Comparator to MLB949	Drug	Placebo

Primary outcome

Frequency and Severity of Adverse Events
Time frame: Baseline to Day 169
Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
Change-from-baseline in Weight
Time frame: Week 16
Baseline weight is defined as the last weight measurement before dosing in kilograms

Results and safety

Results posted to the registry on 31 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MBL949 Arm 1	14	12
MBL949 Arm 2	22	8
MBL949 Arm 3	16	15
MBL949 Arm 4	15	9
MBL949 Arm 5	15	10
Placebo	44	31

Primary outcome: Frequency and Severity of Adverse Events

Time frame: Baseline to Day 169. Count of participants. Unit: Participants

Measure	MBL949 Arm 1 n = 14	MBL949 Arm 2 n = 22	MBL949 Arm 3 n = 16	MBL949 Arm 4 n = 15	MBL949 Arm 5 n = 15	Pooled MBL949 n = 82	Placebo n = 44
Total AEs	11	20	15	10	14	70	30
AEs of mild intensity	10	19	15	10	14	68	29
AEs of moderate intensity	4	8	7	3	8	30	7
AEs of severe intensity	0	2	0	1	0	3	2
Study drug-related AEs	9	18	15	8	12	62	19
Serious AEs	0	0	0	0	0	0	0

Population analysed: Safety Set: included all subjects that received any study drug.

Primary outcome: Change-from-baseline in Weight

Time frame: Week 16. Mean (90% Confidence Interval). Unit: kg

Measure	MBL949 Arm 1 n = 12	MBL949 Arm 2 n = 8	MBL949 Arm 3 n = 15	MBL949 Arm 4 n = 9	MBL949 Arm 5 n = 10	Pooled MBL949 n = 54	Placebo n = 31
Value	-2.6 (-3.8 to -1.5)	-2.0 (-3.3 to -0.8)	-2.0 (-3.0 to -0.9)	-0.1 (-1.4 to 1.1)	0.3 (-0.9 to 1.5)	-1.4 (-2.0 to -0.8)	-0.7 (-1.4 to -0.0)

MBL949 Arm 1 vs Placebo: adjusted means: -1.9 (80% CI -2.9 to -0.9), p = 0.0182, MMRM analysis
MBL949 Arm 2 vs Placebo: adjusted means: -1.3 (80% CI -2.4 to -0.2), p = 0.1205, MMRM analysis
MBL949 Arm 3 vs Placebo: adjusted means: -1.3 (80% CI -2.2 to -0.3), p = 0.0931, MMRM analysis

Population analysed: PD analysis set: included all subjects who received any study drug, had Pharmacodynamics (PD) data, and had no protocol deviations with relevant impact on PD data. Only participants with weight data at Baseline and Week 16 were included in the analysis.

Adverse events

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MBL949 Arm 1	0 of 14 (0%)	11 of 14 (78.6%)	0 of 14
MBL949 Arm 2	0 of 22 (0%)	20 of 22 (90.9%)	0 of 22
MBL949 Arm 3	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16
MBL949 Arm 4	0 of 15 (0%)	10 of 15 (66.7%)	0 of 15
MBL949 Arm 5	0 of 15 (0%)	14 of 15 (93.3%)	0 of 15
Pooled MBL949	0 of 82 (0%)	70 of 82 (85.4%)	0 of 82
Placebo	0 of 44 (0%)	26 of 44 (59.1%)	0 of 44
Total	0 of 126 (0%)	96 of 126 (76.2%)	0 of 126

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on novctrd.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MBL949 in people with Obesity, run by Novartis Pharmaceuticals at 4 sites in United States.

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 7 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: stopped early, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Frequency and Severity of Adverse Events (time frame: Baseline to Day 169). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05199090.

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 9 Oct 2024.