Colorectal CancerPhase 2NCT07033026
An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.
A Phase 2 study testing NGM120 Q4W and NGM120 Q8W in people with Colorectal Cancer and CRC (Colorectal Cancer), run by NGM Biopharmaceuticals, Inc at 28 sites in 4 countries.
Trial summary
A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, CRC (Colorectal Cancer), Cancer Cachexia
- What is being tested?
- NGM120 Q4W and NGM120 Q8W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 28 sitesin 4 countries
- Study dates
- 25 Jun 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented active diagnosis of colorectal cancer.
- Cachexia defined by Fearon criteria of weight loss.
- Signed informed consent.
Who cannot join
- 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 locations and contacts
28 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 4 countries
United States13 sites, 12 recruiting
- Recruiting
NGM Clinical Study Site
Appleton, Wisconsin, 54915
NGM Site 112, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Baltimore, Maryland, 21201
NGM Site 104, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Dallas, Texas, 75390
NGM Site 102, NGM120CX@ngmbio.com
- Withdrawn
NGM Clinical Study Site
Kingwood, Texas, 77339
- Recruiting
NGM Clinical Study Site
Laredo, Texas, 78041
NGM Site 101, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Los Angeles, California, 90033
NGM Site 115, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Los Angeles, California, 90095
NGM Site 105, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Margate, Florida, 33063
NGM Site 106, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
New York, New York, 10065
NGM Site 113, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Richmond, Virginia, 23114
NGM Site 114, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Santa Rosa, California, 95403
NGM Site 103, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Toledo, Ohio, 43608
NGM Site 109, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Youngstown, Ohio, 44504
NGM Site 111, NGM120CX@ngmbio.com
South Korea7 sites, 7 recruiting
- Recruiting
NGM Clinical Study Site
Goyang, 10326
NGM Site 207, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Goyang, 1048
NGM Site 206, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Incheon, 21565
NGM Site 205, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Seoul, 2841
NGM Site 203, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Seoul, 3080
NGM Site 202, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Seoul, 6351
NGM Site 201, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Suwon, 16247
NGM Site 204, NGM120CX@ngmbio.com
Georgia5 sites, 5 recruiting
- Recruiting
NGM Clinical Study Site
Tbilisi, 159
NGM Site 352, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Tbilisi, 159
NGM Site 353, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Tbilisi, 159
NGM Site 354, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Tbilisi, 159
NGM Site 355, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Tbilisi, 186
NGM Site 351, NGM120CX@ngmbio.com
Taiwan3 sites, 3 recruiting
- Recruiting
NGM Clinical Study Site
Taichung, 407216
NGM Site 252, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Taipei, 100225
NGM Site 251, NGM120CX@ngmbio.com
- Recruiting
NGM Clinical Study Site
Taoyuan, 333423
NGM Site 253, NGM120CX@ngmbio.com
About this study
Official title: A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia
A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
Read the detailed description
Evaluation of Efficacy, Safety and Tolerability of NGM120 in a Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Participants with Colorectal Cancer who have Cancer Cachexia
- Conditions
- Colorectal Cancer, CRC (Colorectal Cancer), Cancer Cachexia
- Being tested
- NGM120 Q4W, NGM120 Q8W, Placebo given
- Keywords
- Cancer Cachexia, Colorectal Cancer, CRC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM120 Q4WDrug
NGM120 given subcutaneously every 4 weeks
NGM120 Q8WDrug
NGM120 given subcutaneously every 8 weeks
Placebo givenDrug
Placebo given subcutaneously every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| NGM120 Treatment Group A | Experimental | NGM120 low dose given subcutaneously every 4 weeks Receives: Drug: NGM120 Q4W |
| NGM120 Treatment Group B | Placebo comparator | Placebo low dose given subcutaneously every 4 weeks Receives: Drug: Placebo given |
| NGM120 Treatment Group C | Experimental | NGM120 high dose given subcutaneously every 4 weeks Receives: Drug: NGM120 Q4W |
| NGM120 Treatment Group D | Experimental | NGM120 high dose given subcutaneously every 8 weeks Receives: Drug: NGM120 Q8W |
| NGM120 Treatment Group E | Placebo comparator | Placebo high dose given subcutaneously every 4 weeks Receives: Drug: Placebo given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body weight at Week 12
To evaluate the effect of NGM120 compared to placebo on body weight.
Measured: 12 Weeks
Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
To evaluate safety and tolerability of NGM120
Measured: 44 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start25 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- NGM Study Director, Study director, NGM Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033026
- Sponsor's protocol ID
- 120-CX-202
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia
- ClinicalTrials.gov ID
- NCT07033026
- Acronym / sponsor ID
- 120-CX-202
- Conditions
- Colorectal Cancer, CRC (Colorectal Cancer), Cancer Cachexia
- Keywords
- Cancer Cachexia, Colorectal Cancer, CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
Detailed description
Evaluation of Efficacy, Safety and Tolerability of NGM120 in a Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Participants with Colorectal Cancer who have Cancer Cachexia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NGM120 Treatment Group A | Experimental | Drug: NGM120 Q4WNGM120 low dose given subcutaneously every 4 weeks |
| NGM120 Treatment Group B | Placebo comparator | Drug: Placebo givenPlacebo low dose given subcutaneously every 4 weeks |
| NGM120 Treatment Group C | Experimental | Drug: NGM120 Q4WNGM120 high dose given subcutaneously every 4 weeks |
| NGM120 Treatment Group D | Experimental | Drug: NGM120 Q8WNGM120 high dose given subcutaneously every 8 weeks |
| NGM120 Treatment Group E | Placebo comparator | Drug: Placebo givenPlacebo high dose given subcutaneously every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented active diagnosis of colorectal cancer.
- Cachexia defined by Fearon criteria of weight loss.
- Signed informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGM120 Q4WNGM120 given subcutaneously every 4 weeks | Drug | NGM120 Treatment Group A, NGM120 Treatment Group C |
| NGM120 Q8WNGM120 given subcutaneously every 8 weeks | Drug | NGM120 Treatment Group D |
| Placebo givenPlacebo given subcutaneously every 4 weeks | Drug | NGM120 Treatment Group B, NGM120 Treatment Group E |
Primary outcome
Change from baseline in body weight at Week 12
Time frame: 12 Weeks
To evaluate the effect of NGM120 compared to placebo on body weight.
Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Time frame: 44 Weeks
To evaluate safety and tolerability of NGM120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NGM Study Director study director
NGM Biopharmaceuticals, Inc
28 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NGM120 Q4W and NGM120 Q8W in people with Colorectal Cancer and CRC (Colorectal Cancer), run by NGM Biopharmaceuticals, Inc at 28 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, South Korea, Georgia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NGM Study Director (650-727-8800, NGM120CX@ngmbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in body weight at Week 12 (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.