Overweight or ObesityPhase 2FALCONNCT06854952

A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity

A Phase 2 study testing TERN-601 in people with Overweight or Obesity, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered TERN-601 in adults with overweight or obesity. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Overweight or Obesity
What is being tested?: TERN-601
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 167 participants
Where: 17 sitesUnited States
Study dates: 7 Mar 2025to 19 Sep 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female or male aged 18 to 75 years
Body mass index (BMI) of:
≥ 30 kg/m^2 to < 50 kg/m^2
OR
≥ 27 kg/m^2 to < 30 kg/m^2 with at least 1 weight-related comorbidity
HbA1c < 6.5%
Stable self-reported body weight for at least 3 months prior to study (< 5% body weight gain or loss)

Who cannot join

Have diabetes mellitus
Have obesity induced by medication or other diagnosed endocrinologic disorders
Have had or are planning surgical treatment or device-based therapy for obesity
Lifetime history of suicide attempt

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

FALCON Research Site
Arlington, Virginia, 22206
FALCON Research Site
Beachwood, Ohio, 44122
FALCON Research Site
Birmingham, Alabama, 35294
FALCON Research Site
Boston, Massachusetts, 02114
FALCON Research Site
City of Saint Peters, Missouri, 63303
FALCON Research Site
Dallas, Texas, 75230
FALCON Research Site
Homewood, Alabama, 35209
FALCON Research Site
Houston, Texas, 77079
FALCON Research Site
Louisville, Kentucky, 40213
FALCON Research Site
Marrero, Louisiana, 70072
FALCON Research Site
Medford, Oregon, 97504
FALCON Research Site
Port Orange, Florida, 32127
FALCON Research Site
Rochester, Minnesota, 55905
FALCON Research Site
San Antonio, Texas, 78229
FALCON Research Site
Spring Valley, California, 91978
FALCON Research Site
St. George, Utah, 84790
FALCON Research Site
Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity

Conditions: Overweight or Obesity
Being tested: TERN-601, Matching Placebo
Keywords: overweight, obesity, obese, glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist, GLP-1
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TERN-601Drug
Investigational drug
Matching PlaceboOther
Matching placebo

Study groups in NCT06854952
Study group	Role	What they receive
TERN-601 250 mg	Experimental	Orally administered once daily. Receives: Drug: TERN-601
TERN-601 500 mg (slow titration)	Experimental	Orally administered once daily. Receives: Drug: TERN-601
TERN-601 500 mg	Experimental	Orally administered once daily. Receives: Drug: TERN-601
TERN-601 750 mg	Experimental	Orally administered once daily. Receives: Drug: TERN-601
Matching Placebo	Placebo comparator	Orally administered once daily. Receives: Other: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Body Weight
Percent change (%) in body weight from baseline to Week 12
Measured: 12 weeks

Secondary outcomes (2)

Change in Body Weight (kg)
Change in body weight (kg) from baseline to Week 12
Measured: 12 weeks
≥ 5% Weight Loss
Participants achieving ≥ 5% weight loss
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Mar 202519 Sep 2025

First posted3 Mar 2025
Study start7 Mar 2025
Primary completion19 Aug 2025
Study completion19 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Overweight or ObesityStudies 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: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06854952
Sponsor's protocol ID: TERN601-2003
Acronym: FALCON
Status last verified: Aug 2026
First submitted: 25 Feb 2025
Last updated: 10 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Garvey WT, Rosenstock J, Bays HE, Denham D, Kohli A, Haines M, Jones C, Kwan E, Castelloe E, Marmon T, Kuriakose E, Nelson C. Oral GLP-1RA TERN-601 for Adults With Obesity/Overweight: Placebo-Controlled, Multiple-Ascending-Dose, Phase 1 and 2 Studies. Obesity (Silver Spring). 2026 Sep;34(9):1742-1758. doi: 10.1002/oby.70271. Epub 2026 Jul 30.
PubMed 42528333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overweight or Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity
ClinicalTrials.gov ID: NCT06854952
Acronym / sponsor ID: FALCON / TERN601-2003
Conditions: Overweight or Obesity
Keywords: overweight, obesity, obese, glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist, GLP-1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 7 Mar 2025 (actual)
Primary completion: 19 Aug 2025 (actual)
Study completion: 19 Sep 2025 (actual)
First posted: 3 Mar 2025 (actual)
Results: Posted 10 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
TERN-601 250 mg	Experimental	Drug: TERN-601Orally administered once daily.
TERN-601 500 mg (slow titration)	Experimental	Drug: TERN-601Orally administered once daily.
TERN-601 500 mg	Experimental	Drug: TERN-601Orally administered once daily.
TERN-601 750 mg	Experimental	Drug: TERN-601Orally administered once daily.
Matching Placebo	Placebo comparator	Other: Matching PlaceboOrally administered once daily.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female or male aged 18 to 75 years
Body mass index (BMI) of:
OR
HbA1c < 6.5%
Stable self-reported body weight for at least 3 months prior to study (< 5% body weight gain or loss)

Key exclusion criteria (4 listed)

Have diabetes mellitus
Have obesity induced by medication or other diagnosed endocrinologic disorders
Have had or are planning surgical treatment or device-based therapy for obesity
Lifetime history of suicide attempt

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
TERN-601Investigational drug	Drug	TERN-601 250 mg, TERN-601 500 mg, TERN-601 500 mg (slow titration), TERN-601 750 mg
Matching PlaceboMatching placebo	Other	Matching Placebo

Primary outcome

Percent Change in Body Weight
Time frame: 12 weeks
Percent change (%) in body weight from baseline to Week 12

2 secondary outcomes

Change in Body Weight (kg)
Time frame: 12 weeks
≥ 5% Weight Loss
Time frame: 12 weeks

Results and safety

Results posted to the registry on 10 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TERN-601 250 mg	33	24
TERN-601 500 mg (Slow Titration)	34	28
TERN-601 500 mg	34	28
TERN-601 750 mg	33	29
Matching Placebo	33	27

Primary outcome: Percent Change in Body Weight

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: Percent Change (%)

Measure	TERN-601 250 mg n = 27	TERN-601 500 mg (Slow Titration) n = 28	TERN-601 500 mg n = 28	TERN-601 750 mg n = 28	Matching Placebo n = 26
Value	-2.11 (0.688)	-3.85 (0.687)	-4.87 (0.688)	-3.31 (0.688)	-0.30 (0.701)

TERN-601 250 mg vs Matching Placebo: LSM Difference: -1.81 (90% CI -3.4 to -0.3), p = 0.0561, ANOVA
TERN-601 500 mg (Slow Titration) vs Matching Placebo: LSM Difference: -3.55 (90% CI -5.1 to -2.0), p = 0.0002, ANOVA
TERN-601 500 mg vs Matching Placebo: LSM Difference: -4.58 (90% CI -6.1 to -3.0), p <0.0001, ANOVA

Population analysed: Intent-to-treat population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up (Week 16). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TERN-601 250 mg	0 of 33 (0%)	23 of 33 (69.7%)	0 of 33
TERN-601 500 mg (Slow Titration)	0 of 34 (0%)	25 of 34 (73.5%)	0 of 34
TERN-601 500 mg	1 of 34 (2.9%)	27 of 34 (79.4%)	0 of 34
TERN-601 750 mg	2 of 33 (6.1%)	26 of 33 (78.8%)	0 of 33
Matching Placebo	0 of 33 (0%)	17 of 33 (51.5%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42528333Garvey WT, Rosenstock J, Bays HE, Denham D, Kohli A, Haines M, Jones C, Kwan E, Castelloe E, Marmon T, Kuriakose E, Nelson C. Oral GLP-1RA TERN-601 for Adults With Obesity/Overweight: Placebo-Controlled, Multiple-Ascending-Dose, Phase 1 and 2 Studies. Obesity (Silver Spring). 2026 Sep;34(9):1742-1758. doi: 10.1002/oby.70271. Epub 2026 Jul 30.
Individual participant dataSharing planned: No

Related trials for Overweight or Obesity

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Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
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Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TERN-601 in people with Overweight or Obesity, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 17 sites in United States.

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. 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?

Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Body Weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06854952, which also lists 1 linked publication.

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 10 Aug 2026.