Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name FALCON

NCTNCT06854952Other idTERN601-2003

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Glucagon, does not test it. It appears in the conditions.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 167 participants (actual)
Sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 7 Mar 2025
Primary completion: 19 Aug 2025
Completion: 19 Sept 2025
First posted: 3 Mar 2025
Last update posted: 10 Aug 2026
Conditions: Overweight or Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026

Ph 2
FALCON
NCT06854952
7 Mar 2025 to 19 Sept 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TERN-601Drug
Matching PlaceboOther

Arms5

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(2)

Change in Body Weight (kg)
Time frame · 12 weeks
Registry description
Change in body weight (kg) from baseline to Week 12
≥ 5% Weight Loss
Time frame · 12 weeks
Registry description
Participants achieving ≥ 5% weight loss

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 12 weeks

Percent Change in Body Weight

Group	Value (Percent Change (%))	Spread
TERN-601 250 mg	-2.11	0.688
TERN-601 500 mg (Slow Titration)	-3.85	0.687
TERN-601 500 mg	-4.87	0.688
TERN-601 750 mg	-3.31	0.688
Matching Placebo	-0.30	0.701

Secondary and other outcome results(2)

Secondary outcomeLeast squares mean· 12 weeks

Change in Body Weight (kg)

Group	Value (kg)	Spread
TERN-601 250 mg	-2.23	0.733
TERN-601 500 mg (Slow Titration)	-4.02	0.735
TERN-601 500 mg	-4.97	0.735
TERN-601 750 mg	-3.60	0.740
Matching Placebo	-0.45	0.746

Secondary outcomeCount of participants· 12 weeks

≥ 5% Weight Loss

Group	Value (Participants)
TERN-601 250 mg	4
TERN-601 500 mg (Slow Titration)	11
TERN-601 500 mg	13
TERN-601 750 mg	7
Matching Placebo	4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
TERN-601 250 mgOrally administered once daily.	0 / 33	0 / 33	23 / 33
TERN-601 500 mg (Slow Titration)Orally administered once daily.	0 / 34	0 / 34	25 / 34
TERN-601 500 mgOrally administered once daily.	0 / 34	1 / 34	27 / 34
TERN-601 750 mgOrally administered once daily.	0 / 33	2 / 33	26 / 33
Matching PlaceboOrally administered once daily.	0 / 33	0 / 33	17 / 33

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedGarvey 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. PMID 42528333

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Key Inclusion Criteria: 1. Female or male aged 18 to 75 years 2. Body mass index (BMI) of: 1. ≥ 30 kg/m\^2 to \< 50 kg/m\^2 OR 2. ≥ 27 kg/m\^2 to \< 30 kg/m\^2 with at least 1 weight-related comorbidity 3. HbA1c \< 6.5% 4. Stable self-reported body weight for at least 3 months prior to study (\< 5% body weight gain or loss) Key Exclusion Criteria: 1. Have diabetes mellitus 2. Have obesity induced by medication or other diagnosed endocrinologic disorders 3. Have had or are planning surgical treatment or device-based therapy for obesity 4. Lifetime history of suicide attempt

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