An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNGM Biopharmaceuticals, Inc

About this trial

A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented active diagnosis of colorectal cancer.

Cachexia defined by Fearon criteria of weight loss.

Signed informed consent.

Disqualifiers

Current active reversible causes of decreased food intake.

Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.

Have cachexia caused by other reasons.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NGM120 Q4W

    Drug

    NGM120 given subcutaneously every 4 weeks

  • NGM120 Q8W

    Drug

    NGM120 given subcutaneously every 8 weeks

  • Placebo given

    Drug

    Placebo given subcutaneously every 4 weeks

Treatment groups

136 Participants
are divided into 5 treatment groups
Group A: NGM120 Treatment Group AExperimental treatment 1 intervention
Group B: NGM120 Treatment Group BPlacebo comparator 1 intervention
Group C: NGM120 Treatment Group CExperimental treatment 1 intervention
Group D: NGM120 Treatment Group DExperimental treatment 1 intervention
Group E: NGM120 Treatment Group EPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in body weight at Week 12

To evaluate the effect of NGM120 compared to placebo on body weight.

Time frame
12 Weeks
2

Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug

To evaluate safety and tolerability of NGM120

Time frame
44 Weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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