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

Phase 2

Terminated

• Conditions: Obesity
• Interventions: Drug: MBL949; Drug: Placebo

• Registration Number: NCT05199090
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-20
• Study Start: 2022-02-10
• Primary Completion: 2023-05-11
• Study Completion: 2023-05-11
• Results First Submitted: 2024-05-03
• Results First Submitted QC: 2024-05-30
• Results First Posted: 2024-05-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBL949 Arm 1	MBL949	MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
MBL949 Arm 2	MBL949	MBL949 two 3 mg doses followed by six doses of 4.5 mg
MBL949 Arm 3	MBL949	MBL949 one 12 mg dose followed by seven doses of 4.5 mg
MBL949 Arm 4	MBL949	MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
MBL949 Arm 5	MBL949	MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
Placebo	Placebo	Placebo to MBL949

Primary Outcome Measures

Name	Time	Method
Frequency and Severity of Adverse Events	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	Week 16	Baseline weight is defined as the last weight measurement before dosing in kilograms

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Dallas, Texas, United States