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

• ClinicalTrials.gov Identifier: NCT05199090
• Recruitment Status: Completed
• First Posted: January 20, 2022
• Last Update Posted: August 22, 2023
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: December 17, 2021
• First Posted Date: January 20, 2022
• Last Update Posted Date: August 22, 2023
• Actual Study Start Date: February 10, 2022
• Actual Primary Completion Date: May 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2022)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM
• 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
• Brief Summary: This is 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: The study comprises a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants will be administered MBL949 or placebo at 8 biweekly intervals starting on Day 1 and a 10-week follow-up period
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• Drug: MBL949
  subcutaneous injections administered for 14 weeks
• Drug: Placebo
  Placebo Comparator to MLB949

Study Arms

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

  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 18, 2023): 126
• Original Estimated Enrollment (submitted: January 5, 2022): 106
• Actual Study Completion Date: May 11, 2023
• Actual Primary Completion Date: May 11, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05199090
• Other Study ID Numbers: CMBL949A12201; 2021-004449-19 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: August 2023