NCT05199090

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	MBL949	subcutaneous injections administered for 14 weeks
DRUG	Placebo	Placebo Comparator to MLB949

Timeline

• Start date: 2022-02-10
• Primary completion: 2023-05-11
• Completion: 2023-05-11
• First posted: 2022-01-20
• Last updated: 2024-10-09
• Results posted: 2024-05-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study