SURMOUNT-1: 176-week follow-up

Study record

Population

1,032 participants with obesity and baseline prediabetes from the original SURMOUNT-1 trial.

Read source · Abstract-level extractionPrimary abstract — Methods and Results

Formulation

The registered parent protocol specifies sponsor-supplied tirzepatide or placebo in single-dose autoinjector pens, including the planned 176-week prediabetes follow-up. This documents the planned trial presentation, not equivalence to research products or verification of every dispensed batch.

Read source · Study protocolProtocol I8F-MC-GPHK(b), Section 6.1, printed page 56; study design specifies 176-week prediabetes treatment

Route

Subcutaneous injection.

Read source · Abstract-level extractionPrimary abstract — Methods and Results

Dose & frequency

Assigned 5, 10 or 15 mg weekly.

Read source · Abstract-level extractionPrimary abstract — Methods and Results

Study design

Randomized placebo-controlled subgroup follow-up; not a new independent trial.

Read source · Abstract-level extractionPrimary abstract — Methods and Results

Duration

176 weeks assigned treatment plus 17 weeks off treatment.

Read source · Abstract-level extractionPrimary abstract — Methods and Results

Reported findings

Diabetes diagnosed in 1.3% pooled tirzepatide versus 13.3% placebo by week 176; 2.4% versus 13.7% after the off-treatment period.

Read source · Abstract-level extractionPrimary abstract — Methods and Results

Adverse events

Mostly mild/moderate gastrointestinal events, concentrated during escalation; authors reported no new safety signal.

Read source · Abstract-level extractionPrimary abstract — Methods and Results

Monitoring

Registry safety reporting covers the parent trial through week 193, not only the prediabetes subgroup. A subgroup-specific monitoring schedule is not verified here.

Read source · Registry resultsResults — Adverse Events, Time Frame and Description