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

Recruiting at 4 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Metformin, SGLT2i, DDP4, Acarbose

Disqualifiers: Bariatric surgery, Myocardial infarction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 14 weeks

126 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called MBL949 to help people who are overweight or have Type 2 Diabetes. The study includes a period to check participants' health, followed by several weeks of treatment and a follow-up. MBL949 aims to help manage weight and blood sugar levels better than current treatments.

Will I have to stop taking my current medications?

If you are taking medications for Type 2 Diabetes, you can continue with Metformin, SGLT2 inhibitors, DDP4 inhibitors, or Acarbose, as long as they have been stable for 90 days before joining the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

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

History of bariatric surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, gastric banding, and any other intrabdominal procedures designed for weight loss at screening

Participation in organized weight reduction program within 6 months of screening

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive MBL949 or placebo over 14 weeks with 8 biweekly doses

14 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Treatment Details

Interventions

• MBL949

Participant Groups

Group I: MBL949 Arm 4 Active Control 1 Intervention

MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg

Group II: MBL949 Arm 1 Active Control 1 Intervention

MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg

Group III: MBL949 Arm 5 Active Control 1 Intervention

MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg

Group IV: MBL949 Arm 2 Active Control 1 Intervention

MBL949 two 3 mg doses followed by six doses of 4.5 mg

Group V: MBL949 Arm 3 Active Control 1 Intervention

MBL949 one 12 mg dose followed by seven doses of 4.5 mg

Group VI: Placebo Placebo Group 1 Intervention

Placebo to MBL949

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD