Study to assess safety, tolerability and efficacy of SC administered MBL949 in obese participants with or without T2DM

Phase 1

• Conditions: Obesity; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-004449-19-DK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-07
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Participants must be between 18 to 60 years of age inclusive
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the safety and tolerability of different dosing regimens of MBL949 in obese participants with or without T2DM<br>• To evaluate the effect of different dosing regimens of MBL949 on weight in obese participants with or without T2DM at week 16;Secondary Objective: Not applicable;Primary end point(s): • Frequency and severity of adverse events (AEs)<br>• Change from baseline in weight ;Timepoint(s) of evaluation of this end point: Over numerous visits until End of Study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable