Photo Credit: Eli Lilly Canada Inc.

⚕️ Health Canada Approves Mounjaro® (Tirzepatide) for Use in Children 10 Years and Older Living with Type 2 Diabetes

Wednesday, 08 July 2026 06:42.PM

- In a late-stage trial, Mounjaro® helped children and adolescents aged 10 to 17 years with type 2 diabetes to manage their blood sugar better.
- Mounjaro® is considered safe and effective for adults and children 10 years of age and older with type 2 diabetes. -

Eli Lilly Canada announced today that Mounjaro® (tirzepatide), the first and only Health Canada-authorized once-weekly glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist in type 2 diabetes, is now indicated as an adjunct to diet and exercise to improve glycemic control in pediatric patients living with type 2 diabetes aged 10 to 17 years.

"Managing pediatric type 2 diabetes requires dedicated, evidence-based options that support both patients and their families," said Mathilde Merlet, General Manager and President, Eli Lilly Canada. "This approval provides clinicians and youth living with type 2 diabetes with an additional tool to help manage this complex chronic condition, reflecting our ongoing commitment to bringing therapeutic innovations to Canadians."

Although type 2 diabetes is more common in adults, its incidence in children and adolescents has risen over the past two decades. Youth-onset type 2 diabetes is a more aggressive form of the disease than adult-onset, with greater insulin resistance, faster loss of insulin-producing function, and earlier complications.ii,iii As a result, standard therapies such as metformin and basal insulin often fail to keep blood sugar adequately controlled, underscoring the clear need for additional options.iv,v While Diabetes Canada recommends a target HbA1c of ≤7.0% for most children with type 2 diabetes, they acknowledge that there is evidence to suggest there may be a reduced risk of treatment failure by achieving an HbA1c of less 6.0% within the first 6 months of diagnosis.

This approval was based on results from the SURPASS-PEDS Phase 3 clinical trial, which evaluated the efficacy and safety of Mounjaro® (up to a maximum dose of 10 mg once weekly) in pediatric patients aged 10 to less than 18 years with type 2 diabetes. In the trial, Mounjaro met the primary and all key secondary endpoints, achieving superior improvements in A1C and body mass index (BMI) compared with placebo. At 30 weeks, participants taking Mounjaro (pooled 5 mg and 10 mg doses) achieved an average A1C reduction of 2.0%, compared with 0.2% for placebo, with superior reductions at both individual doses. Mounjaro also reduced BMI -- a measure that accounts for growth over time when assessing weight change in children and adolescents -- by an average of 8.9% for pooled doses, compared with 0.6% for placebo.vi

The safety profile was consistent with that observed in adults. Most common adverse events with tirzepatide were mild-to-moderate gastrointestinal events, primarily during dose escalation and decreasing over time.

About Mounjaro®

Mounjaro (tirzepatide injection) is indicated for once-weekly administration as an adjunct to diet and exercise to improve glycemic control for the treatment of:

• Pediatric patients aged 10 to less than 18 years with type 2 diabetes mellitus in combination with:
• metformin, or
• basal insulin with or without metformin

Mounjaro® (tirzepatide) is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and children 10 years of age and older.i As the first and only Health Canada-approved GIP and GLP-1 receptor agonist in type 2 diabetes, Mounjaro® is a single molecule that activates the body's receptors for GIP and GLP-1.

SOURCE: Eli Lilly Canada Inc.

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