Peptide Pipeline
Readout · ClinicalTrials.gov record and conference abstract

AMG 133 phase 1 demonstrates up to 14.5% weight loss after 12 weeks

Reported by Amgen Inc. on Dec 8, 2022

What was reported

AMG 133 phase 1 demonstrates up to 14.5% weight loss after 12 weeks — a ClinicalTrials.gov record and conference abstract readout reported by Amgen Inc. on Dec 8, 2022. Linked to trial NCT03548935.

ClinicalTrials.gov record and conference abstract

Related entities

Assets
Maritide
Companies
Amgen

Design

Phase 1 single and multiple ascending dose study of AMG 133 in adults with overweight or obesity.

Primary endpoint

Safety, tolerability, and pharmacokinetics

Result

At highest dose, mean weight reduction of 14.5% observed 85 days after last dose.

Missing data

Small sample size; exploratory endpoints.

Caveats

Phase 1 design not powered for efficacy; data presented at conference.

Comparison

Results supported advancement into phase 2 and monthly-dosing hypothesis.

Pipeline changes

Phase 2 initiated; maritide designation adopted.

Unknowns

Durability, immunogenicity, and phase 2 dose-selection remain to be determined.

Comparator

Placebo

Effect size

Dose-dependent weight loss with prolonged pharmacodynamic effect.

Discontinuations

No dose-limiting toxicities; GI events mild to moderate.

Adverse events

Nausea and vomiting were most frequent; no serious treatment-related events.

Sources