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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05199090
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics (PK) of subcutaneous (SC) MBL949 in obese participants with or without type 2 diabetes mellitus (T2DM) on weight loss.

Condition or disease Intervention/treatment Phase
Obesity Drug: MBL949 Drug: Placebo Phase 2

Detailed Description:

The purpose of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics (PK) of subcutaneous (SC) MBL949 in obese participants with or without T2DM on weight loss.

Eligible participants will be evaluated for status of glucose homeostasis for stratified enrolment based on whether they are normoglycemic, have impaired glucose tolerance or T2DM.

Participants will be randomized to one of five MBL949 arms or placebo, administered by subcutaneous (SC) injection during the treatment period:

MBL949 Arm 1: One dose C followed by two doses E followed by five doses D of MBL949 Arm 2: Two doses C followed by six doses D of MBL949 Arm 3: One dose G followed by seven doses D of MBL949 Arm 4: One dose A followed by seven doses B of MBL949 Arm 5: One dose C followed by two doses E followed by five doses F of MBL949.

Participants will be evaluated for safety, tolerability, efficacy, and PK during the treatment and follow-up period

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2022
Estimated Primary Completion Date : March 28, 2023
Estimated Study Completion Date : March 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MBL949 Arm 1
One dose C followed by two doses E followed by five doses D of MBL949
Drug: MBL949
subcutaneous injections administered for 14 weeks

Active Comparator: MBL949 Arm 2
Two doses C followed by six doses D of MBL949
Drug: MBL949
subcutaneous injections administered for 14 weeks

Active Comparator: MBL949 Arm 3
One dose G followed by seven doses D of MBL949
Drug: MBL949
subcutaneous injections administered for 14 weeks

Active Comparator: MBL949 Arm 4
One dose A followed by seven doses B of MBL949
Drug: MBL949
subcutaneous injections administered for 14 weeks

Active Comparator: MBL949 Arm 5
One dose C followed by two doses E followed by five doses F of MBL949
Drug: MBL949
subcutaneous injections administered for 14 weeks

Placebo Comparator: Placebo

MBL949 Arm 1, MBL949 Arm 2 and placebo to be enrolled in a 1:1:1 ratio

MBL949 Arm 3, MBL949 Arm 4 and placebo to be enrolled in a 1:1:1 ratio

If MBL949 Arm 1 is tolerated, MBL949 Arm 5 to be enrolled with a 2:1 ratio (MBL:placebo) within each stratum. MBL949 arm 5 will have 12 participants and 6 participants added to placebo arm

Drug: Placebo
Placebo Comparator to MLB949




Primary Outcome Measures :
  1. Frequency and severity of Adverse Events [ Time Frame: Baseline to Day 169 ]
    Primary endpoints for safety and tolerability are occurrences and severities of adverse events by number and percentage of participants reported after the first dose of study medication or events present prior to treatment but increase in severity

  2. Change-from-baseline in weight [ Time Frame: Week 16 ]
    Baseline weight is defined as the last weight measurement before dosing in kilograms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05199090


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Florida
Novartis Investigative Site Recruiting
Miami Beach, Florida, United States, 33140
United States, North Carolina
Novartis Investigative Site Recruiting
Morehead City, North Carolina, United States, 28557
United States, Tennessee
Novartis Investigative Site Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
Novartis Investigative Site Recruiting
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05199090    
Other Study ID Numbers: CMBL949A12201
2021-004449-19 ( EudraCT Number )
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 diabetes mellitus
weight loss