What is mazdutide?

Mazdutide is a long-acting, once-weekly, injectable medicine that is under development for obesity and type 2 diabetes. It is currently undergoing phase 3 clinical trials and is not expected to be submitted for FDA approval until pre-marketing clinical trials have finished, and results have continued to be favorable.

How does mazdutide work?

Mazdutide is a dual glucagon-like peptide 1 receptor agonist (GLP-1RA) and glucagon receptor agonist, the first in its class. By activating both GLP1R and glucagon receptors it helps regulate appetite, metabolism, and improve glucose control. This dual effect appears promising but more clinical trials are needed.

GLP-1 receptors are widely distributed on the beta-cells of the pancreas, brain, and other tissues and are involved in the control of blood sugar levels by enhancing insulin secretion, among other effects. GLP-1 receptor agonists (GLP-1RAs) are already widely used in the treatment of type 2 diabetes because they stimulate insulin synthesis and secretion in a glucose-dependent manner and cause weight loss. They also delay gastric emptying, regulate blood lipid metabolism, reduce fat deposition, and are neuroprotective, anti-infectious, and cardiovascular protective.

Glucagon receptor agonists on their own are not a good therapeutic option because they increase the liver's production of glucose, but if they are combined with GLP-1RAs then they are effective at reducing fat mass and improving glucose tolerance.

What are the side effects of mazdutide?

Clinical trials have so far reported mazdutide to be well tolerated with mild side effects such as:

• upper respiratory tract infection
• diarrhea
• decreased appetite
• nausea
• urinary tract infection
• abdominal distension (bloating)
• vomiting.

How is mazdutide administered?

Mazdutide is administered using a prefilled autoinjector and is given subcutaneously (under the skin), usually in the stomach area, once a week.

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How effective is mazdutide?

Mazdutide is currently undergoing phase 3 clinical trials to assess its effectiveness.

A phase 2 study of 80 adults who received 9mg mazdutide once a week for 24 weeks reported:

• Superior body weight loss with mazdutide with a mean percent change in body weight from baseline versus placebo of -15.4% with a reported treatment difference of 14.7 kg
• Nobody in the placebo group lost 5% or more of their body weight from baseline.
• The authors received funding from Innovent Biologics Inc.

A phase 2 study of 248 participants randomized to receive one of 3 dosing schedules for mazdutide reported:

• An average 7.21% decrease in body weight after 24 weeks. Higher dosages were associated with a higher weight loss (6.35kg on 3mg, 9.07kg on 4.5mg, and 9.85kg on 6mg mazdutide)
• A total of 230 participants (92.7%) completed week 24
• Body-mass index, blood pressure, waist circumference, and liver fat content were all reduced. Lipid levels and insulin sensitivity were improved and transaminase and serum uric acid levels lowered
• The authors received funding from Innovent Biologics Inc.

A phase 1b trial (Ji et al., 2022) of 24 patients (8 received mazdutide 9mg, 8 received mazdutide 10mg, and the rest placebo) reported:

• Those receiving 9mg mazdutide lost an average of 9.8% more weight than those receiving a placebo (an inactive treatment) after 12 weeks
• Those receiving 10mg mazdutide lost an average of 6.2% more weight than those receiving a placebo after 16 weeks
• More profound reductions in waist circumference and BMI were reported with mazdutide
• The authors received funding from Innovent Biologics Inc.

Who makes mazdutide?

Mazdutide is manufactured by Innovent Biologics under a licensing agreement with Eli Lilly and Company (Lilly).

Is mazdutide known by any other name?

Mazdutide is also known as OXM3.