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

Obesity Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT05199090
• Study type: Interventional
• Source: Novartis
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 10, 2022
• Completion date: June 19, 2023